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

February 22, 2024 updated by: Glaukos Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Edward Manche, MD
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Recruiting
        • Chu Vision Institute, P.A.
        • Contact:
        • Principal Investigator:
          • Ralph Chu, MD
    • Montana
      • Bozeman, Montana, United States, 59718
    • North Dakota
      • W. Fargo, North Dakota, United States, 58078
    • Ohio
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • Comprehensive EyeCare of Central Ohio
        • Contact:
        • Principal Investigator:
          • Kenneth Beckman, MD
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • Vantage Eye Care, LLC
        • Contact:
        • Principal Investigator:
          • Brandon Ayres, MD
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Recruiting
        • Carolina Cataract & Laser Center
        • Contact:
        • Principal Investigator:
          • David Vroman, MD
    • Texas
      • Houston, Texas, United States, 77027
        • Recruiting
        • Slade & Baker Vision
        • Contact:
        • Principal Investigator:
          • Stephen Slade, MD
    • Utah
      • Draper, Utah, United States, 84020
        • Recruiting
        • Hoopes Vision
        • Contact:
        • Principal Investigator:
          • Majid Moshirfar, MD
    • Virginia
      • McLean, Virginia, United States, 22102
        • Recruiting
        • See Clearly Vision Group
        • Contact:
        • Principal Investigator:
          • Christine Tagayun, MD
    • Washington
      • Seattle, Washington, United States, 98133
        • Recruiting
        • Northwest Eye Surgeons
        • Contact:
        • Principal Investigator:
          • Audrey Rostov, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with corneal ectasia following refractive surgery who are planning to undergo or have undergone corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information.

Description

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 study visits;
  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 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. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CXL Group
Patients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information
Combination product: Corneal Collagen Cross-linking
Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kmax
Time Frame: 36 months
Change from pretreatment baseline in maximum corneal curvature
36 months
BCVA
Time Frame: 36 month
Change from pretreatment baseline in BCVA
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Investigators

  • Study Director: Kerry Stephens, Glaukos Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-KXL-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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