Status:
COMPLETED
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Cataracts
Eligibility:
All Genders
Brief Summary
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05991960
Start Date
September 11 2023
End Date
December 4 2023
Last Update
February 2 2024
Active Locations (12)
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1
Assil Eye Institute
Beverly Hills, California, United States, 90210
2
The Eye Institute of West Florida
Largo, Florida, United States, 33770
3
Center for Sight
Sarasota, Florida, United States, 34239
4
Aloha Vision Consultants
Honolulu, Hawaii, United States, 96816