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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1674 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-21

Study Completion Date

2025-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Refractive Error Glaucoma Cataracts Clear Lens Exchange

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Intervention

No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No