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

Launched by JOHNSON & JOHNSON SURGICAL VISION, INC. · May 24, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.