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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cataracts
• Intervention / Treatment: Device: Intervention

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 714-478-1176; Email: pnilplub@its.jnj.com

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye and Laser Center
  • Florida
    • Venice, Florida, United States, 34285
      • Center For Sight
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Waring Vision Institute
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Bilateral pseudophakic subjects previously implanted with the 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 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuities	Visual Acuity will be collected via observed case data in units of logMAR.	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 6, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: DIOL111MOLS

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