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

NCT06005675 | Completed FDA Device

• 1 other identifier: DIOL111MOLS
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• Visual Acuities

  Visual Acuity will be collected via observed case data in units of logMAR.

  1-month postoperative

Interventions

Intervention DEVICE

No study treatments will be administered during this study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bilateral pseudophakic subjects previously implanted with the TECNIS Odyssey IOL

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (4)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

Center For Sight

Venice, Florida, 34285, United States

Location

Waring Vision Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Methods

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Johnson & Johnson, Surgical Vision Inc. Clinical Trial

  Johnson & Johnson Surgical Vision, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: September 6, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)