Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia (CL)

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: NCT00567671
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : September 2, 2010
Information provided by:
Emory University

Brief Summary:
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Condition or disease Intervention/treatment Phase
Progressive Keratoconus Corneal Ectasia Procedure: Corneal collagen Procedure: Sham comparator Phase 2 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 at least 12 months to evaluate the long term effects of corneal collagen cross-linking.

Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover 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 or Progressive Keratoconus
Study Start Date : December 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Treatment
Corneal collagen cross-linking
Procedure: Corneal collagen
Corneal collagen cross-linking with riboflavin/UVA light

Sham Comparator: Control
Sham Treatment
Procedure: Sham comparator
Sham treatment

Primary Outcome Measures :
  1. Change in keratometry [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Best spectacle-corrected visual acuity [ Time Frame: 3 Months ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Diagnosis of keratoconus with documented progression over the previous 12 months.
  • Diagnosis of corneal ectasia
  • Must be able to complete all study visits

Exclusion Criteria:

  • Prior corneal surgery in the keratoconus group
  • Corneal scarring

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 identifier (NCT number): NCT00567671

United States, Georgia
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
Sponsors and Collaborators
Emory University
Principal Investigator: R. Doyle Stulting, MD, PhD Emory Vision; Emory University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: R. Doyle Stulting, MD, PhD., Professor of Ophthalmology, Emeritus, Principle Investigator, Woolfson Eye Intitute Identifier: NCT00567671     History of Changes
Other Study ID Numbers: UVX-001
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: July 2009

Keywords provided by Emory University:
UVA light

Additional relevant MeSH terms:
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical