Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 8:28 PM
Study NCT ID:
NCT02923232
Status:
TERMINATED
Last Update Posted:
2023-05-03
First Post:
2016-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shunnan.yang@pacificu.edu', 'phone': '5033522852', 'title': 'Dr. Shun-nan Yang', 'organization': 'Pacific University'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of wear, usually no more than 30 mins.', 'description': 'This is a non-prescription study involving only temporarily worn contact lens for a period of 30 mins during which refractive error and acuity of tested eyes were measured. As such, there is no expected risk in mortality and serious adverse effects.', 'eventGroups': [{'id': 'EG000', 'title': 'Accommodative Contact Lens', 'description': 'This was a study involving only the test contact lens. There is no control condition.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Monocular Refractive Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accommodative Contact Lens', 'description': 'This was a study involving only the test contact lens. There is no control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 mins of wearing; non-dispensing.', 'description': 'Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.', 'unitOfMeasure': 'Diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Presbyopes who require distance optical correction'}, {'type': 'PRIMARY', 'title': 'Visual Acuity at 20 Degree Downsize Angles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accommodative Contact Lens', 'description': 'This was a study involving only the test contact lens. There is no control condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 mins of wearing; non-dispensing.', 'description': 'The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Presbyopes who require distance optical correction'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accommodative Contact Lens', 'description': 'This was a study involving only the test contact lens. There is no control condition.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The study was not completed due to the withdraw of research funding.', 'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study involved few participants recruited from Pacific University and designated clinics. It went through 3 iterations in lens design changes and less than 10 subjects in each iteration.', 'preAssignmentDetails': 'Subjects were recruited in 3 separate iterations. They were not assigned to different groups, and were tested with the same test lens with minor modification. This is considered a phase 1 study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Accommodative Contact Lens', 'description': 'The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.\n\nAccommodative contact lens: Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.'}], 'measures': [{'title': 'Age, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'classes': [{'title': 'Age at the entrance date', 'categories': [{'measurements': [{'value': '52.6', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Monocular visual acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '.4', 'spread': '.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Subjects wore no optical correction and their distance monocular acuity was assessed.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'eyes'}], 'typeUnitsAnalyzed': 'eyes', 'populationDescription': 'Presbyopes'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-10-01', 'size': 186479, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-05-22T12:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Funding organization requested to stop the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2016-09-29', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2016-10-02', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-28', 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocular Refractive Power', 'timeFrame': '30 mins of wearing; non-dispensing.', 'description': 'Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.'}, {'measure': 'Visual Acuity at 20 Degree Downsize Angles', 'timeFrame': '30 mins of wearing; non-dispensing.', 'description': 'The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens; Accommodation; Visual performance'], 'conditions': ['Functionality of Experimental Contact Lens']}, 'descriptionModule': {'briefSummary': 'Presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) will be recruited to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.', 'detailedDescription': 'In the proposed study we plan to recruit presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles. These are similar to the typical examinations conducted for regular contact lens wearers. Results of this testing will be used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses. If shown to provide adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to adapt to contact lenses and significantly improve their vision and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 40 and 65 years of age.\n* Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.\n* Have pupil diameter in regular lighting ≥ 2.5 mm.\n* Willing and able to wear multifocal contact lenses in both eyes.\n* Have a current optical prescription (obtained less than 2 years ago).\n* Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter.\n* Have cylindrical correction equal to less than 0.50 Diopter.\n\nExclusion Criteria:\n\n* Have no prismatic correction.\n* Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months.\n* No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration)\n* Have no photosensitive disorders, including migraine and seizure.\n* Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases.'}, 'identificationModule': {'nctId': 'NCT02923232', 'acronym': 'ACL', 'briefTitle': 'Ocular Adaptation and Visual Performance for Accommodative Contact Lens', 'organization': {'class': 'OTHER', 'fullName': 'Pacific University'}, 'officialTitle': 'Ocular Adaptation and Visual Performance for Accommodative Contact Lens', 'orgStudyIdInfo': {'id': 'OFV-S1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accommodative contact lens', 'description': 'The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.', 'interventionNames': ['Device: Accommodative contact lens']}], 'interventions': [{'name': 'Accommodative contact lens', 'type': 'DEVICE', 'description': 'Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.', 'armGroupLabels': ['Accommodative contact lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97116', 'city': 'Forest Grove', 'state': 'Oregon', 'country': 'United States', 'facility': 'Vision Performance Institute', 'geoPoint': {'lat': 45.51984, 'lon': -123.11066}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research at VPI', 'investigatorFullName': 'Shun-nan Yang', 'investigatorAffiliation': 'Pacific University'}}}}