Status:
COMPLETED
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Cataracts
Eligibility:
All Genders
Brief Summary
Prospective 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 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
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 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
Key Trial Info
Start Date :
September 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06005675
Start Date
September 6 2023
End Date
May 1 2024
Last Update
April 25 2025
Active Locations (4)
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1
Empire Eye and Laser Center
Bakersfield, California, United States, 93309
2
Center For Sight
Venice, Florida, United States, 34285
3
Waring Vision Institute
Mt. Pleasant, South Carolina, United States, 29464
4
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108