Cataracts, Clear Lens Exchange, Glaucoma, Refractive Error
Conditions
Brief summary
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Interventions
DEVICEIntervention
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.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | up to 12 months post-operation | incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints. |
| BCDVA | up to 12 months post-operation | The proportion of eyes achieving 20/40 or better BCDVA. |
Countries
Germany, Spain, United States
Outcome results
None listed