Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

Last updated: February 22, 2024
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Corneal Collagen Cross-linking

Clinical Study ID

NCT03319082
ACP-KXL-401
  • Ages > 18
  • All Genders

Study Summary

The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be at least 18 years of age, male or female, of any race;
  2. Provide written informed consent and sign a HIPAA form;
  3. Willingness and ability to follow all instructions and comply with schedule for studyvisits;
  4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
  5. Planning to undergo (or have undergone within the past 90 days) corneal collagencross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribinginformation (NOTE: Complete treatment and follow-up data, including anyproduct-related events at time of procedure through the time of enrollment must beavailable);
  6. For females capable of becoming pregnant, agree to have urine pregnancy testingperformed prior to enrolling in the registry; must not be pregnant or lactating.

Exclusion

Exclusion Criteria:

  1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior toenrollment in the registry;
  2. The Investigator may exclude or discontinue any patient for any sound medical reason.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Corneal Collagen Cross-linking
Phase:
Study Start date:
October 04, 2017
Estimated Completion Date:
February 28, 2026

Study Description

Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.

Connect with a study center

  • Stanford University School of Medicine

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Chu Vision Institute, P.A.

    Bloomington, Minnesota 55420
    United States

    Active - Recruiting

  • Vance Thompson Vision - MT

    Bozeman, Montana 59718
    United States

    Active - Recruiting

  • Vance Thompson Vision - ND

    W. Fargo, North Dakota 58078
    United States

    Active - Recruiting

  • Comprehensive EyeCare of Central Ohio

    Westerville, Ohio 43082
    United States

    Active - Recruiting

  • Vantage Eye Care, LLC

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Active - Recruiting

  • Carolina Cataract & Laser Center

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Waring Vision Institute

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Slade & Baker Vision

    Houston, Texas 77027
    United States

    Active - Recruiting

  • Hoopes Vision

    Draper, Utah 84020
    United States

    Active - Recruiting

  • See Clearly Vision Group

    McLean, Virginia 22102
    United States

    Active - Recruiting

  • Northwest Eye Surgeons

    Seattle, Washington 98133
    United States

    Active - Recruiting

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