Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-26 @ 8:24 AM
Study NCT ID:
NCT02521766
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2015-08-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. Clinical Trial Lead, CDMA Surgical', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.', 'description': 'Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (Ocular)', 'description': 'HMIOL implantation with no optic exchange\n\nEvents reported in this group occurred in the study eye from time of consent to study exit (up to 15 months)', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 2, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 2 Pre-exchange (Ocular)', 'description': 'HMIOL implantation pre-optic exchange\n\nEvents reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 1, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cohort 2 Post-exchange (Ocular)', 'description': 'HMIOL implantation post-optic exchange\n\nEvents reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 6, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fellow Eye (Ocular)', 'description': 'IOL per standard of care\n\nEvents reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2)', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 5, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Systemic (Non-ocular)', 'description': 'Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2)', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neovascular age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Capsule Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular lens implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange'}], 'classes': [{'title': 'Month 1 postoperative', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative', 'description': "Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}], 'classes': [{'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}], 'classes': [{'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fellow Eye', 'description': 'IOL implantation per standard of care'}], 'classes': [{'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange'}], 'classes': [{'title': 'Week 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}], 'classes': [{'title': 'Week 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}], 'classes': [{'title': 'Week 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 post-exchange: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 post-exchange: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 post-exchange: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 post-exchange: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 post-exchange: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 post-exchange: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 post-exchange: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 post-exchange: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 post-exchange: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 post-exchange: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fellow Eye', 'description': 'IOL implantation per standard of care'}], 'classes': [{'title': 'Month 1 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative: Within ± 0.5 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative: Within ± 1.0 D of Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange'}], 'classes': [{'title': 'Day -90 to Day -1 preoperative', 'categories': [{'measurements': [{'value': '75.2', 'spread': '14.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'categories': [{'measurements': [{'value': '84.6', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'categories': [{'measurements': [{'value': '85.4', 'spread': '3.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean BCDVA (Letters Read) by Study Visit - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}], 'classes': [{'title': 'Day -90 to -1 preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.9', 'spread': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.8', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.7', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean BCDVA (Letters Read) by Study Visit - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}], 'classes': [{'title': 'Day -90 to -1 preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.8', 'spread': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.1', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.2', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.6', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.5', 'spread': '9.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean BCDVA (Letters Read) by Study Visit - Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fellow Eye', 'description': 'IOL implantation per standard of care'}], 'classes': [{'title': 'Day -90 to -1 preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.3', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.9', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.9', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange'}], 'classes': [{'title': 'Day 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.5', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.4', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}], 'classes': [{'title': 'Day 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.8', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.7', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.1', 'spread': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.1', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.9', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}], 'classes': [{'title': 'Day 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.1', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.1', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.2', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.8', 'spread': '13.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.8', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.7', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'spread': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.2', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 post-optic exchange', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fellow Eye', 'description': 'IOL implantation per standard of care'}], 'classes': [{'title': 'Day 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.6', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.3', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.3', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.4', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.0', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.1', 'spread': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}]}, {'units': 'eyes', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 Day 1 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'OG001', 'title': 'Cohort 2 Week 1 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'OG002', 'title': 'Cohort 2 Month 1 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'OG003', 'title': 'Cohort 2 Month 3 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'OG004', 'title': 'Cohort 2 Month 6 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'OG005', 'title': 'Cohort 2 Month 12 Post-optic Exchange', 'description': 'HMIOL implantation with optic exchange'}], 'classes': [{'title': '20/20 Snellen or Better', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}, {'value': '53.1', 'groupId': 'OG002'}, {'value': '49.2', 'groupId': 'OG003'}, {'value': '55.6', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}]}]}, {'title': '20/25 Snellen or Better', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}, {'value': '69.2', 'groupId': 'OG001'}, {'value': '70.3', 'groupId': 'OG002'}, {'value': '81.0', 'groupId': 'OG003'}, {'value': '79.4', 'groupId': 'OG004'}, {'value': '74.2', 'groupId': 'OG005'}]}]}, {'title': '20/32 Snellen or Better', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '87.7', 'groupId': 'OG001'}, {'value': '92.2', 'groupId': 'OG002'}, {'value': '93.7', 'groupId': 'OG003'}, {'value': '93.7', 'groupId': 'OG004'}, {'value': '83.9', 'groupId': 'OG005'}]}]}, {'title': '20/40 Snellen or Better', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}, {'value': '93.8', 'groupId': 'OG001'}, {'value': '96.9', 'groupId': 'OG002'}, {'value': '96.8', 'groupId': 'OG003'}, {'value': '98.4', 'groupId': 'OG004'}, {'value': '95.2', 'groupId': 'OG005'}]}]}, {'title': 'Worse than 20/40 Snellen', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '3.2', 'groupId': 'OG003'}, {'value': '1.6', 'groupId': 'OG004'}, {'value': '4.8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned.", 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}, {'type': 'PRIMARY', 'title': 'Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange'}], 'classes': [{'title': 'With glare', 'categories': [{'measurements': [{'value': '81.0', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Without glare', 'categories': [{'measurements': [{'value': '81.1', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Per Protocol Population, with available data at the visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Per Protocol', 'comment': 'Successful HMIOL implantation without a major protocol deviation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 3 investigational sites located in the Philippines (2) and New Zealand (1).', 'preAssignmentDetails': 'Of the 217 enrolled, 101 subjects did exit the study prior to implantation, and 2 subjects failed implantation of Harmoni Modular Intraocular Lens (HMIOL). This reporting group includes all subjects with successful HMIOL implantation (114) by subgroup (Cohort 1 and Cohort 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per Protocol: All subjects with successful HMIOL implantation without a major protocol deviation, by subgroup (Cohort 1 and Cohort 2)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-14', 'size': 9502234, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-07T13:31', 'hasProtocol': True}, {'date': '2017-02-24', 'size': 1357024, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-07T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2018-03-02', 'completionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2015-08-06', 'dispFirstSubmitQcDate': '2018-03-02', 'resultsFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2015-08-10', 'dispFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-09', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative', 'description': "Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned."}, {'measure': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned."}, {'measure': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned"}, {'measure': 'Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned."}, {'measure': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2', 'timeFrame': 'Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye', 'timeFrame': 'Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': 'A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort', 'timeFrame': 'Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean BCDVA (Letters Read) by Study Visit - Cohort 1', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean BCDVA (Letters Read) by Study Visit - Cohort 2', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean BCDVA (Letters Read) by Study Visit - Fellow Eye', 'timeFrame': 'Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye', 'timeFrame': 'Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.'}, {'measure': 'Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2', 'timeFrame': 'Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange', 'description': "VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned."}, {'measure': 'Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort', 'timeFrame': 'Month 3 postoperative', 'description': 'VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract', 'IOL', 'Modular IOL', 'IOL exchange'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The main objectives of this feasibility study were:\n\n* To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and\n* To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).', 'detailedDescription': 'Eligible subjects with bilateral cataracts underwent cataract extraction and IOL implantation using phacoemulsification. The study eye was implanted with the investigational device (All HMIOL Cohort). The fellow eye was treated with a commercially available intraocular lens (IOL) per standard of care procedure. At the scheduled Month 3 post-operative visit, subjects who did not opt to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 1 and followed for an additional 6 months. The total duration of participation for Cohort 1 was up to 15 months, which included a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. At the scheduled Month 3 post-operative visit, subjects who elected to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 2 and followed for an additional 12 months. The total duration of participation for Cohort 2 was up to 18 months, which included a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period.\n\nAlcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc., to evaluate the safety and effectiveness of the HMIOL. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to understand and provide informed consent\n* Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration\n* Planned bilateral removal of visually significant bilateral cataracts\n* Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes\n* Preoperative bilateral BCDVA of 20/40 or worse\n* Both eyes must have corneal astigmatism ≤ 1.50 diopter (D)\n* Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study\n* Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation\n* History of any intraocular or corneal surgery in either eye (including refractive)\n* History of any clinically significant retinal pathology or ocular diagnosis in either eye\n* History of any ocular conditions which could affect the stability of the IOL\n* Uncontrolled glaucoma in either eye\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02521766', 'briefTitle': 'A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'ClarVista Medical'}, 'officialTitle': 'A Prospective, Multi-Center, Feasibility Trial of the ClarVista HARMONI™ Modular Intraocular Lens System for the Treatment of Aphakia Following Cataract Surgery', 'orgStudyIdInfo': {'id': 'CP-00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All HMIOL Cohort', 'description': 'HMIOL implantation with or without optic exchange', 'interventionNames': ['Device: Harmoni Modular Intraocular Lens']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'HMIOL implantation with no optic exchange', 'interventionNames': ['Device: Harmoni Modular Intraocular Lens']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'HMIOL implantation with optic exchange', 'interventionNames': ['Device: Harmoni Modular Intraocular Lens', 'Procedure: Optic exchange']}, {'type': 'OTHER', 'label': 'Fellow Eye', 'description': 'IOL implantation per standard of care', 'interventionNames': ['Device: Commercially Available Intraocular Lens']}], 'interventions': [{'name': 'Harmoni Modular Intraocular Lens', 'type': 'DEVICE', 'otherNames': ['HMIOL'], 'description': 'Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag', 'armGroupLabels': ['All HMIOL Cohort', 'Cohort 1', 'Cohort 2']}, {'name': 'Commercially Available Intraocular Lens', 'type': 'DEVICE', 'description': "IOL per investigator's standard of care", 'armGroupLabels': ['Fellow Eye']}, {'name': 'Optic exchange', 'type': 'PROCEDURE', 'description': 'Removal of one optic and replacement with another for the purpose of improving refractive outcomes', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'ClarVista Investigational Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '1200', 'city': 'Makati City', 'state': 'Manila', 'country': 'Philippines', 'facility': 'ClarVista Investigational Site', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}], 'overallOfficials': [{'name': 'Sr. CDMA Project Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ClarVista Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}