Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-18 @ 10:29 PM
Study NCT ID:
NCT03226561
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uNVC (3000K)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 3000 Kelvins'}, {'measure': 'uNVC (4000K)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 4000 Kelvins'}, {'measure': 'uNVC (6000K)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 6000 Kelvins'}, {'measure': 'uNVC (25FC)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 25 Foot Candles'}, {'measure': 'uNVC (50FC)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 50 Foot Candles'}, {'measure': 'uNVC (75FC)', 'timeFrame': '6 months', 'description': 'Uncorrected Near Vision Capacity at 75 Foot Candles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'referencesModule': {'references': [{'pmid': '30587911', 'type': 'DERIVED', 'citation': 'Labiris G, Ntonti P, Panagiotopoulou EK, Konstantinidis A, Gkika M, Dardabounis D, Perente I, Sideroudi H. Impact of light conditions on reading ability following multifocal pseudophakic corrections. Clin Ophthalmol. 2018 Dec 14;12:2639-2646. doi: 10.2147/OPTH.S180766. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation', 'detailedDescription': 'Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPresbyopia\n\nExclusion Criteria:\n\nGlaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity'}, 'identificationModule': {'nctId': 'NCT03226561', 'briefTitle': 'Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation', 'orgStudyIdInfo': {'id': '334/20-7-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Panoptix Group', 'description': 'Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)', 'interventionNames': ['Procedure: Phaco / Panoptix']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control, age-matched presbyopic group corrected with presbyopic glasses'}], 'interventions': [{'name': 'Phaco / Panoptix', 'type': 'PROCEDURE', 'description': 'Phacoemulsification with bilateral diffractive trifocal lens implantation', 'armGroupLabels': ['Panoptix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'Democritus University of Thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}