Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT06401551
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2024-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clareon PanOptix Pro vs. Clareon PanOptix - Study B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-19', 'mcpReleaseN': 7, 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Contralateral (split face) study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)', 'timeFrame': 'Month 2 postoperative', 'description': 'Visual Acuity (VA) will be assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract', 'IOL'], 'conditions': ['Aphakia', 'Presbyopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.', 'detailedDescription': 'Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Understand and sign an ethics committee-approved informed consent form;\n* Willing and able to attend all scheduled study visits as required by the protocol;\n* Planned cataract surgery (both eyes);\n* Preoperative corneal astigmatism less that 1.00 diopter in each eye.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;\n* Ocular conditions as specified in the protocol;\n* Subjects who desire monovision correction.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06401551', 'briefTitle': 'Clareon PanOptix Pro vs. Clareon PanOptix - Study B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix', 'orgStudyIdInfo': {'id': 'ILQ137-C002-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPO Pro IOL', 'description': 'CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.', 'interventionNames': ['Device: CPO Pro IOL', 'Device: CPO IOL', 'Procedure: Cataract Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'CPO IOL', 'description': 'CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.', 'interventionNames': ['Device: CPO Pro IOL', 'Device: CPO IOL', 'Procedure: Cataract Surgery']}], 'interventions': [{'name': 'CPO Pro IOL', 'type': 'DEVICE', 'otherNames': ['Clareon PanOptix Pro'], 'description': 'Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.', 'armGroupLabels': ['CPO IOL', 'CPO Pro IOL']}, {'name': 'CPO IOL', 'type': 'DEVICE', 'otherNames': ['Clareon PanOptix'], 'description': 'Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.', 'armGroupLabels': ['CPO IOL', 'CPO Pro IOL']}, {'name': 'Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.', 'armGroupLabels': ['CPO IOL', 'CPO Pro IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '48302', 'city': 'Bloomfield Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Grosinger, Spigelman & Grey Eye Surgeons, P.C.', 'geoPoint': {'lat': 42.58364, 'lon': -83.24549}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eye Care Physicians', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vision for Life', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The Eye Institute of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Principal Clinical Trial Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}