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Corneal Collagen Cross-Linking for Ectasia (CXL) (CXL)

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ClinicalTrials.gov Identifier: NCT00674661
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : January 27, 2017
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Study Description
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Brief Summary:
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Condition or disease Intervention/treatment Phase
Ectasia Drug: riboflavin ophthalmic solution Device: UVA Irradiation Phase 3

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. 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
Study Start Date : December 2007
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: UV-X™ Illumination System
Sham Comparator: Control Group
riboflavin opthalmic solution without UVA irradiation
 Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ectasia after refractive surgery
  • Documented ectasia on Pentacam or topography map
  • BSCVA worse than 20/20
  • Must complete all study visits

Exclusion Criteria:

  • History of delayed wound healing
  • History of corneal melt or corneal dystrophy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674661


Locations
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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
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
Glaukos Corporation
Investigators
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Principal Investigator: Peter Hersh, MD Cornea and Laser Eye Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00674661    
Other Study ID Numbers: UVX-003
First Posted: May 8, 2008    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: June 15, 2018
Last Verified: June 2018
Keywords provided by Glaukos Corporation:
ectasia
cross-linking
crosslinking
 cornea
riboflavin
UVA
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical
Riboflavin
Ophthalmic Solutions
Pharmaceutical Solutions
Vitamin B Complex
Vitamins
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents