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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: January 24, 2014
Last verified: January 2014

March 28, 2008
January 24, 2014
December 2007
April 2011   (final data collection date for primary outcome measure)
Change in keratometry [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Change in keratometry [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00647699 on ClinicalTrials.gov Archive Site
Not Provided
Bestspectacle-corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647699
UVX-002
No
Avedro, Inc.
Avedro, Inc.
Not Provided
Principal Investigator: Peter Hersh, MD Cornea and Laser Institute
Avedro, Inc.
January 2014

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