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

Completed

Conditions studied: Cataracts

In brief

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

Key facts

Study ID

NCT05991960

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

96

Starts

2023-09-11

Expected to finish

2023-12-04

Last updated by the study team

2024-02-02

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 consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

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 within the retrospective analysis window;
• Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
• 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.).
• Amblyopia, strabismus, nystagmus in each eye.

Where it is running

• Assil Eye Institute — Beverly Hills, California, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• Center for Sight — Sarasota, Florida, United States
• Aloha Vision Consultants — Honolulu, Hawaii, United States
• OCLI Vision — Garden City, New York, United States
• Vance Thompson Vision — West Fargo, North Dakota, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Carolina EyeCare Physicians — Mt. Pleasant, South Carolina, United States
• Loden Vision Centers — Goodlettsville, Tennessee, United States
• Dell Laser Consultants — Austin, Texas, United States
• Whitsett Vision Group — Houston, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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