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

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

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Intervention

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Assil Eye Institute
  • Florida
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
    • Sarasota, Florida, United States, 34239
      • Center For Sight
  • Hawaii
    • Honolulu, Hawaii, United States, 96816
      • Aloha Vision Consultants
  • New York
    • Garden City, New York, United States, 11530
      • OCLI Vision
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Eyecare Physicians
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Loden Vision Centers
  • Texas
    • Austin, Texas, United States, 78746
      • Dell Laser Consultants
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: DIOL112MRWD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes