Cataracts
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 the subject device 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. 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 consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
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 within the retrospective analysis window; 4. Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator; 5. Acute or chronic disease or condition, ocular trauma or surgery that may affect vision in each eye (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 Acuity | 1-month postoperative | Visual Acuity will be collected via observed case data in units of logMAR. |
| Manifest Refraction | 1-month postoperative | Manifest Refraction will be collected via observed case data in units of diopters. |
| Visual Symptoms/Complaints | 1-month postoperative | Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale. |
Countries
United States
Outcome results
None listed