A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

• Conditions: Refractive Error; Glaucoma; Cataracts; Clear Lens Exchange

• Registration Number: NCT05394324
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-06-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
2. Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

Exclusion Criteria

1. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
2. Use of surgical devices not in accordance with the product labeling or indications for use
3. Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
4. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
5. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
6. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCDVA	up to 12 months post-operation	The proportion of eyes achieving 20/40 or better BCDVA.
Incidence of Adverse Events	up to 12 months post-operation	incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.

Trial Locations

Locations (13)

Clinica Vistahermosa; 🇪🇸 Alicante, Alacant, Spain

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Trinity Research Group, LLC; 🇺🇸 Dothan, Alabama, United States

Empire Eye and Laser Center; 🇺🇸 Bakersfield, California, United States

Chu Vision Institute; 🇺🇸 Bloomington, Minnesota, United States

Hospital La Arruzafa; 🇪🇸 Cordoba, Andalusia, Spain

Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH; 🇩🇪 Ahaus, Nordrhein-Westfalen, Germany

Augenzentrum Erzgebirge; 🇩🇪 Zschopau, SN, Germany

Hosp. De La Santa Creu I Sant Pau; 🇪🇸 Barcelona, CT, Spain

Instituto Universitario de Oftalmobiologia Aplicada; 🇪🇸 Valladolid, CL, Spain

Augentagesklinik Spreebogen Berlin GbR; 🇩🇪 Berlin, Germany

Hospital Clinico San Carlos; 🇪🇸 Madrid, MD, Spain

Clinica Oftalvist; 🇪🇸 Madrid, Spain