RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery

Quick Facts

Study Start:2017-10-04
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03319082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be at least 18 years of age, male or female, of any race;
  2. 2. Provide written informed consent and sign a HIPAA form;
  3. 3. Willingness and ability to follow all instructions and comply with schedule for study visits;
  4. 4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
  5. 5. Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
  6. 6. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to enrolling in the registry; must not be pregnant or lactating.
  1. 1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
  2. 2. The Investigator may exclude or discontinue any patient for any sound medical reason.

Contacts and Locations

Study Contact

Kerry Stephens, OD
CONTACT
949-481-8057
kstephens@glaukos.com

Principal Investigator

Kerry Stephens
STUDY_DIRECTOR
Glaukos Corporation

Study Locations (Sites)

Stanford University School of Medicine
Palo Alto, California, 94303
United States
Chu Vision Institute, P.A.
Bloomington, Minnesota, 55420
United States
Vance Thompson Vision - MT
Bozeman, Montana, 59718
United States
Vance Thompson Vision - ND
W. Fargo, North Dakota, 58078
United States
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, 43082
United States
Vantage Eye Care, LLC
Bala-Cynwyd, Pennsylvania, 19004
United States
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
United States
Slade & Baker Vision
Houston, Texas, 77027
United States
Hoopes Vision
Draper, Utah, 84020
United States
See Clearly Vision Group
McLean, Virginia, 22102
United States
Northwest Eye Surgeons
Seattle, Washington, 98133
United States

Collaborators and Investigators

Sponsor: Glaukos Corporation

  • Kerry Stephens, STUDY_DIRECTOR, Glaukos Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-04
Study Completion Date2026-02

Study Record Updates

Study Start Date2017-10-04
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Corneal Ectasia