User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataracts

Treatments: Device: Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06005675

DIOL111MOLS

Details and patient eligibility

About

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

Enrollment: 44 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 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