Status:
COMPLETED
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Refractive Error
Glaucoma
Eligibility:
All Genders
Brief Summary
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
1674 Patients enrolled
Trial Details
Trial ID
NCT05394324
Start Date
June 21 2022
End Date
May 31 2025
Last Update
July 20 2025
Active Locations (13)
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1
Trinity Research Group, LLC
Dothan, Alabama, United States, 36301
2
Empire Eye and Laser Center
Bakersfield, California, United States, 93309
3
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
4
Valley Retina Institute
McAllen, Texas, United States, 78503