Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647699
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : July 7, 2016
Last Update Posted : June 15, 2018
Information provided by (Responsible Party):
Avedro, Inc.

March 28, 2008
April 1, 2008
May 2, 2016
July 7, 2016
June 15, 2018
December 2007
April 2011   (Final data collection date for primary outcome measure)
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.
Change in keratometry [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00647699 on Archive Site
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Bestspectacle-corrected visual acuity [ Time Frame: 3 months ]
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Corneal Collagen Cross-linking for Progressive Keratoconus
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Progressive Keratoconus
  • 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
  • Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group
    riboflavin ophthalmic solution and UVA irradiation
    • Drug: riboflavin ophthalmic solution
    • Device: UVA Irradiation
  • Sham Comparator: Control Group
    riboflavin ophthalmic solution without UVA irradiation.
    Intervention: Drug: riboflavin ophthalmic solution
Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Avedro, Inc.
Avedro, Inc.
Not Provided
Principal Investigator: Peter Hersh, MD Cornea and Laser Institute
Avedro, Inc.
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP