Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-04-17 @ 5:35 AM
Study NCT ID:
NCT07147192
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of an Accommodating IOL Design
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': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Contralateral implantation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)', 'timeFrame': 'From Day 0 up to Month 12', 'description': "The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1."}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract'], 'conditions': ['Aphakia']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.', 'detailedDescription': 'This study will enroll adult subjects who require cataract surgery in both eyes. One eye will receive the AAL-FAIOL and the other eye will receive the BAL-FAIOL. The two eye surgeries will be separated by 14-35 days. Subjects will attend follow up visits for approximately 1 year. If needed, the AAL lens may be adjusted after surgery with a laser to help give the participant better vision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand and sign an Informed Consent Form.\n* Willing and able to attend all scheduled study visits required per protocol.\n* Diagnosed with bilateral cataracts requiring removal by phacoemulsification.\n* Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding.\n* Taking medications that could increase risk or may affect accommodation.\n* Eye conditions as specified in the protocol, including glaucoma or ocular hypertension.\n* Medical conditions that could increase operative risk as specified in the protocol.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07147192', 'briefTitle': 'Feasibility Study of an Accommodating IOL Design', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Feasibility Study of an Accommodating IOL Design', 'orgStudyIdInfo': {'id': 'ILK345-E001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AAL-FAIOL', 'description': 'The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.', 'interventionNames': ['Device: AAL-FAIOL', 'Procedure: Phacoemulsification']}, {'type': 'EXPERIMENTAL', 'label': 'BAL-FAIOL', 'description': 'The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.', 'interventionNames': ['Device: BAL-FAIOL', 'Procedure: Phacoemulsification']}], 'interventions': [{'name': 'AAL-FAIOL', 'type': 'DEVICE', 'description': 'Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject. Laser energy to specified locations can be used to allow a change in power for far distances.', 'armGroupLabels': ['AAL-FAIOL']}, {'name': 'BAL-FAIOL', 'type': 'DEVICE', 'description': 'Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.', 'armGroupLabels': ['BAL-FAIOL']}, {'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'description': 'Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.', 'armGroupLabels': ['AAL-FAIOL', 'BAL-FAIOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'San José', 'status': 'NOT_YET_RECRUITING', 'country': 'Costa Rica', 'facility': 'Clinica 20/20', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Santo Domingo', 'status': 'NOT_YET_RECRUITING', 'country': 'Dominican Republic', 'facility': 'Instituto Espaillat Cabral', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'San Salvador', 'status': 'NOT_YET_RECRUITING', 'country': 'El Salvador', 'facility': 'Centro Panamericano de Ojos / Clinica Lopez Beltran', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}, {'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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}