Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-19 @ 5:27 AM
Study NCT ID:
NCT03706066
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
India PanOptix Post Marketing Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation', 'timeFrame': 'Month 3 (following second eye surgery)', 'description': 'Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.', 'detailedDescription': 'The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;\n* Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;\n* Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.\n\nExclusion Criteria:\n\n* Pregnant or lactating, current or planned, during the course of the study;\n* Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);\n* Clinically significant corneal abnormalities;\n* History of retinal conditions;\n* Previous refractive surgery, including LASIK;\n* Glaucoma;\n* Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion.\n\nOther protocol-specified inclusion and/or exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03706066', 'briefTitle': 'India PanOptix Post Marketing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population', 'orgStudyIdInfo': {'id': 'ILD432-P001'}, 'secondaryIdInfos': [{'id': 'CTRI/2018/11/016467', 'type': 'OTHER', 'domain': 'CTRI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PanOptix', 'description': 'Cataract surgery with implantation of Acrysof IQ PanOptix IOL', 'interventionNames': ['Device: Acrysof IQ PanOptix IOL', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'Acrysof IQ PanOptix IOL', 'type': 'DEVICE', 'otherNames': ['Model TFNT00'], 'description': 'Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery', 'armGroupLabels': ['PanOptix']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': "Per investigator's standard of care", 'armGroupLabels': ['PanOptix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380052', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '600006', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '641002', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '560010', 'city': 'Bangalore', 'country': 'India', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Laboratories (India) PVT.LTD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}