Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataracts

Treatments: Device: Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05991960

DIOL112MRWD

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Volunteers: No Healthy Volunteers

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.