Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

April 22, 2021 updated by: Glaukos Corporation

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Shiley Eye Center
      • San Diego, California, United States, 91222
        • Gordon -Weiss Vision Institute
    • Florida
      • Miami, Florida, United States, 33176
        • Center for Excellence in Eye Care
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Kansas
      • Kansas City, Kansas, United States, 66211
        • Durrie Vision
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute at Johns Hopkins University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Eye Consultants
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Cornea & Laser Eye Institute; Hersh Vision Group
    • New York
      • New York, New York, United States, 10032
        • Edward Harkness Eye Institute at Columbia University Medical Center
      • Rockville Centre, New York, United States, 11570
        • Ophthalmic Consultants of Long Island

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of keratoconus
  • Documented progression over previous 24 months
  • Decreased BSCVA
  • Must complete all study visits

Exclusion Criteria:

  • Prior corneal surgery or Intacs
  • History of delayed wound healing

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Device: UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Other Names:
  • UV-X Illumination System
Sham Comparator: Control Group
riboflavin ophthalmic solution without UVA irradiation.
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Maximum Keratometry (Kmax)
Time Frame: baseline,12 months
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
baseline,12 months

Collaborators and Investigators

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

Sponsor

Glaukos Corporation

Investigators

  • Principal Investigator: Peter Hersh, MD, Cornea and Laser Institute

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

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

December 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVX-002

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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