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

Completed

Conditions studied: Cataracts

In brief

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

Key facts

Study ID

NCT06005675

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

44

Starts

2023-09-06

Expected to finish

2024-05-01

Last updated by the study team

2025-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
• Enrollment at least 21 days after second eye surgery;
• Clear intraocular media in each eye;
• Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
• Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
• Ability to understand, read, and write in English

You may not qualify if…

• Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
• Use of systemic or ocular medication that may affect vision
• 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;
• Ongoing adverse events that might impact study measurements, as determined by the investigator;
• 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.);
• Amblyopia, strabismus, nystagmus in each eye

Where it is running

• Empire Eye and Laser Center — Bakersfield, California, United States
• Center For Sight — Venice, Florida, United States
• Waring Vision Institute — Mt. Pleasant, South Carolina, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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