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

NCT05991960 | Completed FDA Device

• 1 other identifier: DIOL112MRWD
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Cataracts

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Intervention DEVICE

No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with the subject device of 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

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

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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (12)

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Center for Sight

Sarasota, Florida, 34239, United States

Location

Aloha Vision Consultants

Honolulu, Hawaii, 96816, United States

Location

OCLI Vision

Garden City, New York, 11530, United States

Location

Vance Thompson Vision

West Fargo, North Dakota, 58078, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Carolina EyeCare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

Loden Vision Centers

Goodlettsville, Tennessee, 37072, United States

Location

Dell Laser Consultants

Austin, Texas, 78746, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, 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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: September 11, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (12)