Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT04196569
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2019-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trifocal Intraocular Lens (IOL) Aberrometry Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of spectacle independence (overall)', 'timeFrame': '1 month post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Percentage spectacle independence (overall)', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}], 'secondaryOutcomes': [{'measure': 'Spectacle independence for distance, intermediate and near', 'timeFrame': '1 month post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Spectacle independence for distance, intermediate and near', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)', 'timeFrame': '1 month post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be measured by visual acuity'}, {'measure': 'Subject satisfaction', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.'}, {'measure': 'Uncorrected binocular and monocular visual acuity at all distances', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be measured by visual acuity'}, {'measure': 'Distribution of residual refractive error', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be measured by refractive error'}, {'measure': 'Contrast sensitivity (binocular)', 'timeFrame': '1 month post-cataract surgery', 'description': 'This will be measured by contrast sensitivity testing'}, {'measure': 'Contrast sensitivity (binocular)', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be measured by contrast sensitivity testing'}, {'measure': 'Percentage of subjects with <=0.50 D of refractive cylinder', 'timeFrame': '1 month post-cataract surgery', 'description': 'This will be measured by refractive error'}, {'measure': 'Percentage of subjects with <=0.50 D of refractive cylinder', 'timeFrame': '3 months post-cataract surgery', 'description': 'This will be measured by refractive error'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trifocal lens', 'trifocal intraocular lens', 'aberrometry'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to consent to study and cataract surgery\n* Visually significant cataract\n* Potential post-operative visual acuity of 20/25 or better\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss\n* Irregular astigmatism\n* Prior corneal refractive surgery'}, 'identificationModule': {'nctId': 'NCT04196569', 'briefTitle': 'Trifocal Intraocular Lens (IOL) Aberrometry Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis', 'orgStudyIdInfo': {'id': '19-05020251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'trifocal intraocular lens', 'interventionNames': ['Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses']}], 'interventions': [{'name': 'Alcon Trifocal and Trifocal Toric Intraocular Lenses', 'type': 'DEVICE', 'description': 'Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics:\n\nTFAT30, TFAT40, TFAT50, TFAT60', 'armGroupLabels': ['trifocal intraocular lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ashley Brissette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}