Cataracts
Conditions
Brief summary
Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Interventions
DEVICEIntervention
No study treatments will be administered during this study.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction; 2. Enrollment at least 21 days after second eye surgery; 3. Clear intraocular media in each eye; 4. Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries; 5. Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures; 6. Ability to understand, read, and write in English
Exclusion criteria
1. Concurrent participation in an interventional clinical trial during the time from which the data will be collected; 2. Use of systemic or ocular medication that may affect vision 3. Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits; 4. Ongoing adverse events that might impact study measurements, as determined by the investigator; 5. Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.); 6. Amblyopia, strabismus, nystagmus in each eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuities | 1-month postoperative | Visual Acuity will be collected via observed case data in units of logMAR. |
Countries
United States
Outcome results
None listed