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

Last updated: February 1, 2024
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Overall Status: Completed

Phase

N/A

Condition

Vision Loss

Cataracts

Eye Disorders/infections

Treatment

Intervention

Clinical Study ID

NCT05991960
DIOL112MRWD
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataractextraction;
  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 applicableprivacy laws pertaining to medical treatment in the governing countries.

Exclusion

Exclusion Criteria:

  1. Concurrent participation in an interventional clinical trial during the time fromwhich 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 visitas determined by the investigator;
  5. Acute or chronic disease or condition, ocular trauma or surgery that may affect visionin each eye (e.g., clinically significant macular degeneration, glaucoma, cystoidmacular edema, proliferative diabetic retinopathy, keratoconus etc.).
  6. Amblyopia, strabismus, nystagmus in each eye.

Study Design

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: Intervention
Phase:
Study Start date:
September 11, 2023
Estimated Completion Date:
December 04, 2023

Connect with a study center

  • Assil Eye Institute

    Beverly Hills, California 90210
    United States

    Site Not Available

  • The Eye Institute of West Florida

    Largo, Florida 33770
    United States

    Site Not Available

  • Center for Sight

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Aloha Vision Consultants

    Honolulu, Hawaii 96816
    United States

    Site Not Available

  • OCLI Vision

    Garden City, New York 11530
    United States

    Site Not Available

  • Vance Thompson Vision

    W. Fargo, North Dakota 58078
    United States

    Site Not Available

  • Cleveland Eye Clinic

    Brecksville, Ohio 44141
    United States

    Site Not Available

  • Carolina EyeCare Physicians

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Loden Vision Centers

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Dell Laser Consultants

    Austin, Texas 78746
    United States

    Site Not Available

  • Whitsett Vision Group

    Houston, Texas 77055
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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