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

This study has been completed.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00567671
First received: December 3, 2007
Last updated: September 1, 2010
Last verified: July 2009
  Purpose

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 Intervention Phase
Progressive Keratoconus
Corneal Ectasia
Procedure: Corneal collagen
Procedure: Sham comparator
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 Corneal Ectasia or Progressive Keratoconus

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in keratometry [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best spectacle-corrected visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: December 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567671

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

Additional Information:
No publications provided

Responsible Party: R. Doyle Stulting, MD, PhD., Professor of Ophthalmology, Emeritus, Principle Investigator, Woolfson Eye Intitute
ClinicalTrials.gov Identifier: NCT00567671     History of Changes
Other Study ID Numbers: UVX-001
Study First Received: December 3, 2007
Last Updated: September 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
keratoconus
ectasia
cross-linking
riboflavin
UVA light
cornea

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

ClinicalTrials.gov processed this record on July 22, 2014