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

Johnson & Johnson (J&J)

Status: Invitation-only

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

Treatments: Device: Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05394324

JJSV301PMCF

Details and patient eligibility

About

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

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.