Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-06-26 @ 5:11 AM
Study NCT ID:
NCT02049567
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accommodative amplitude', 'timeFrame': 'Month 6', 'description': 'Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.'}, {'measure': 'Best corrected distance visual acuity (BCDVA)', 'timeFrame': 'Month 6', 'description': 'Visual acuity of the eye will be tested with the correction in place.'}, {'measure': 'Rates of adverse events', 'timeFrame': 'Up to Month 36', 'description': 'Adverse events will be collected from time of enrollment to study exit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract'], 'conditions': ['Aphakia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.', 'detailedDescription': 'Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;\n* Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);\n* Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;\n* Willing and able to comply with schedule for follow-up visits for 36 months after surgery.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);\n* Taking systemic medications that may confound the outcome or increase the risk to the subject;\n* Ocular conditions that may predispose for future complications;\n* Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;\n* Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;\n* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02049567', 'briefTitle': 'Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PowerVision'}, 'officialTitle': 'Clinical Evaluation of the FluidVision Accommodating Intraocular Lens', 'orgStudyIdInfo': {'id': 'AIOL-2009-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FluidVision', 'description': 'FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery', 'interventionNames': ['Device: FluidVision AIOL', 'Procedure: Cataract Surgery']}], 'interventions': [{'name': 'FluidVision AIOL', 'type': 'DEVICE', 'description': 'Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject', 'armGroupLabels': ['FluidVision']}, {'name': 'Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Performed using standard microsurgical techniques', 'armGroupLabels': ['FluidVision']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': 'D-70176', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '44892', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '10559', 'city': 'Berlin', 'country': 'Germany', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '7708', 'city': 'Claremont', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': -33.98056, 'lon': 18.46528}}, {'zip': '2195', 'city': 'Northcliff', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': -26.14619, 'lon': 27.97068}}, {'zip': '2001', 'city': 'Queenswood', 'state': 'Pretoria', 'country': 'South Africa', 'facility': 'PowerVision Investigative Site', 'geoPoint': {'lat': -25.72969, 'lon': 28.25323}}, {'zip': '7130', 'city': 'Paardevlei', 'state': 'Somerset West', 'country': 'South Africa', 'facility': 'PowerVision Investigative Site'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PowerVision', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}