Corneal Collagen Cross-linking for Progressive Keratoconus - Full Text View

Sponsor:	Avedro, Inc.
Information provided by:	Avedro, Inc.
ClinicalTrials.gov Identifier:	NCT00647699

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	Procedure: Cross-linking with riboflavin/UVA light Procedure: Sham comparator	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover 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:

MedlinePlus related topics: Corneal Disorders

Drug Information available for: Riboflavin

U.S. FDA Resources

Further study details as provided by Avedro, Inc.:

Primary Outcome Measures:

Change in keratometry [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Bestspectacle-corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: CXL Corneal collagen cross-linking with riboflavin and UVA light	Procedure: Cross-linking with riboflavin/UVA light Corneal collagen cross-linking with riboflavin/UVA light Other Names: CXL UVX UVX-002 cross-linking crosslinking
Sham Comparator: Sham Sham treatment	Procedure: Sham comparator Sham treatment with riboflavin in the absence of UVA light Other Names: CXL UVX UVX-002 Cross-linking Crosslinking

Detailed Description:

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Fellow eyes may be treated at 3 months or later. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Eligibility

Ages Eligible for Study:	14 Years and older
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

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

Locations

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

No publications provided

Responsible Party:	Maureen O'Connell, Regulatory Consultant, Avedro, Inc.
ClinicalTrials.gov Identifier:	NCT00647699 History of Changes
Other Study ID Numbers:	UVX-002
Study First Received:	March 28, 2008
Last Updated:	July 20, 2010
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
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 21, 2012