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

Completed

Conditions studied: Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange

In brief

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

Key facts

Study ID

NCT05394324

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

1674

Starts

2022-06-21

Expected to finish

2025-05-31

Last updated by the study team

2025-07-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
• 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.

You may not qualify if…

• Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
• Use of surgical devices not in accordance with the product labeling or indications for use
• 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
• Use of systemic or ocular medications that may affect vision during the retrospective data collection period
• Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
• Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Where it is running

• Trinity Research Group, LLC — Dothan, Alabama, United States
• Empire Eye and Laser Center — Bakersfield, California, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• Valley Retina Institute — McAllen, Texas, United States
• Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH — Ahaus, North Rhine-Westphalia, Germany
• Augenzentrum Erzgebirge — Zschopau, Saxony, Germany
• Augentagesklinik Spreebogen Berlin GbR — Berlin, Germany
• Clinica Vistahermosa — Alicante, Alacant, Spain
• Hospital La Arruzafa — Córdoba, Andalusia, Spain
• Instituto Universitario de Oftalmobiologia Aplicada — Valladolid, CL, Spain
• Hosp. De La Santa Creu I Sant Pau — Barcelona, CT, Spain
• Hospital Clinico San Carlos — Madrid, MD, Spain
• Clinica Oftalvist — Madrid, Spain

Full record on ClinicalTrials.gov

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