Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-21 @ 2:00 PM
Study NCT ID:
NCT07161635
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)', 'timeFrame': 'Month 1 and Month 6 postoperative', 'description': 'Visual Acuity (VA) will be assessed for both eyes together (binocular) 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': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract', 'Eye Surgery'], 'conditions': ['Aphakia', 'Presbyopia']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.", 'detailedDescription': 'Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);\n* Subject must be able to understand and sign an approved informed consent form;\n* Subject is willing to complete all the required study visits for the duration of the study;\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Ocular conditions as specified in the protocol;\n* Subjects who desire monovision correction;\n* Previous intraocular or corneal surgery;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07161635', 'briefTitle': 'Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs', 'orgStudyIdInfo': {'id': 'ILQ137-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clareon PanOptix Pro/Pro Toric Trifocal IOL', 'description': 'The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.', 'interventionNames': ['Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL', 'Procedure: Phacoemulsification']}], 'interventions': [{'name': 'Clareon PanOptix Pro/Pro Toric Trifocal IOL', 'type': 'DEVICE', 'otherNames': ['Clareon PanOptix Pro Trifocal IOL Models PXYWT0, PXCWT0, PXYAT0, PXCAT0', 'Clareon PanOptix Pro Trifocal Toric IOL Models PXYWT3- PXYWT6, PXCWT3-T6, PXYAT3-PXYAT6, PXCAT3-PXCAT6'], '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': ['Clareon PanOptix Pro/Pro Toric Trifocal IOL']}, {'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'description': 'Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.', 'armGroupLabels': ['Clareon PanOptix Pro/Pro Toric Trifocal IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Carolina Eyecare Physicians LLC', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Eye Institute of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Alcon Call Center', 'role': 'CONTACT', 'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937'}], 'overallOfficials': [{'name': 'Sr. Principal Clinical Trial Operations, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}