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

Completed

• Conditions: Cataracts

• Registration Number: NCT06005675
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-22
• Study Start: 2023-09-06
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuities	1-month postoperative	Visual Acuity will be collected via observed case data in units of logMAR.

Trial Locations

Locations (4)

Waring Vision Institute; 🇺🇸 Mount Pleasant, South Carolina, United States

Empire Eye and Laser Center; 🇺🇸 Bakersfield, California, United States

Center For Sight; 🇺🇸 Venice, Florida, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States