Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.
ClinicalTrials.gov Identifier:
NCT00647699
First received: March 28, 2008
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Progressive Keratoconus
Drug: riboflavin ophthalmic solution
Device: UVA Irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus

Resource links provided by NLM:


Further study details as provided by Avedro, Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline in Maximum Keratometry (Kmax) [ Time Frame: baseline,12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 147
Study Start Date: December 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)

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.
  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647699

Locations
United States, California
Shiley Eye Center
La Jolla, California, United States, 92093
Gordon -Weiss Vision Institute
San Diego, California, United States, 91222
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
United States, Kansas
Durrie Vision
Overton (Kansas City), Kansas, United States, 66211
United States, Maryland
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
Cornea & Laser Eye Institute; Hersh Vision Group
Teaneck, New Jersey, United States, 07666
United States, New York
Edward Harkness Eye Institute at Columbia University Medical Center
New York, New York, United States, 10032
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Avedro, Inc.
Investigators
Principal Investigator: Peter Hersh, MD Cornea and Laser Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Avedro, Inc.
ClinicalTrials.gov Identifier: NCT00647699     History of Changes
Other Study ID Numbers: UVX-002 
Study First Received: March 28, 2008
Results First Received: May 2, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Avedro, Inc.:
keratoconus
cross-linking
riboflavin
UVA light
cornea

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 25, 2016