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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
History of Changes
  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
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:
Click here to contact the investigator site for this study.  This link exits the ClinicalTrials.gov site

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 June 18, 2013