Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-12 @ 8:01 AM
Study NCT ID:
NCT05317728
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Cohort 1 is a subject and assessor-masked comparison. Cohort 2 does not utilize masking.'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cohort 1 utilizes a parallel-group study design. Cohort 2 utilizes a single-group study design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)', 'timeFrame': 'Month 6 post second eye implantation', 'description': 'Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). This outcome measure is pre-specified for Cohort 1 and Cohort 2.'}, {'measure': 'Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)', 'timeFrame': 'Up to Year 1', 'description': "The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for Cohort 1 BAL-FAIOL IOL only."}, {'measure': 'Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2', 'timeFrame': 'Up to Year 1', 'description': "The number of adverse events, including SSI's, will be calculated from time of implantation. The outcome measure is pre-specified for Cohort 2 only"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IOL', 'Intraocular lens'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).', 'detailedDescription': 'In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.\n\nThis study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.\n\nThis study will be conducted in Central America.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;\n* Willing and able to attend all scheduled study visits as required by the protocol;\n* Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Subjects taking medications that may affect accommodation;\n* Clinically significant eye abnormalities as specified in the protocol;\n* Previous eye surgery as specified in the protocol;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05317728', 'briefTitle': 'Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control', 'orgStudyIdInfo': {'id': 'ILR286-E002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: BAL-FAIOL', 'description': 'BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)', 'interventionNames': ['Device: BAL-FAIOL IOL', 'Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1: Monofocal', 'description': 'Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)', 'interventionNames': ['Device: Monofocal IOL', 'Procedure: Cataract surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: BAL-FAIOL', 'description': 'BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)', 'interventionNames': ['Device: BAL-FAIOL IOL', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'BAL-FAIOL IOL', 'type': 'DEVICE', 'description': 'Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject', 'armGroupLabels': ['Cohort 1: BAL-FAIOL', 'Cohort 2: BAL-FAIOL']}, {'name': 'Monofocal IOL', 'type': 'DEVICE', 'otherNames': ['AcrySof IQ monofocal IOL (SN60WF)'], 'description': 'Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject', 'armGroupLabels': ['Cohort 1: Monofocal']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Phacoemulsification with a clear cornea incision', 'armGroupLabels': ['Cohort 1: BAL-FAIOL', 'Cohort 1: Monofocal', 'Cohort 2: BAL-FAIOL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San José', 'status': 'RECRUITING', 'country': 'Costa Rica', 'facility': 'Clinica 20/20', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': '10124', 'city': 'Santo Domingo', 'status': 'COMPLETED', 'country': 'Dominican Republic', 'facility': 'Laser Center SA', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'zip': '45116', 'city': 'Zapopan', 'state': 'Jalisco', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Mexico', 'facility': 'Centro de Retina Medica y Quirurgica SC', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': '04030', 'city': 'Mexico City', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Mexico', 'facility': 'Asociación Para Evitar la Ceguera en México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '06600', 'city': 'Mexico City', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Mexico', 'facility': 'Salauno Salud SAPI de CV', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'facility': 'Panama Eye Center', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Alcon Call Center', 'role': 'CONTACT', 'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937'}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}