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

Completed

• Conditions: Cataracts

• Registration Number: NCT05991960
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-09-11
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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 within the retrospective analysis window;
4. Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
5. 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.).
6. Amblyopia, strabismus, nystagmus in each eye.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Manifest Refraction	1-month postoperative	Manifest Refraction will be collected via observed case data in units of diopters.
Visual Symptoms/Complaints	1-month postoperative	Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.
Visual Acuity	1-month postoperative	Visual Acuity will be collected via observed case data in units of logMAR.

Trial Locations

Locations (12)

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; 🇺🇸 W. Fargo, North Dakota, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Carolina EyeCare Physicians; 🇺🇸 Mount Pleasant, South Carolina, United States

Loden Vision Centers; 🇺🇸 Goodlettsville, Tennessee, United States

Dell Laser Consultants; 🇺🇸 Austin, Texas, United States

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