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The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rush Eye Associates
Sponsor:
Information provided by (Responsible Party):
Rush Eye Associates
ClinicalTrials.gov Identifier:
NCT01708538
First received: October 15, 2012
Last updated: November 3, 2014
Last verified: November 2014

October 15, 2012
November 3, 2014
October 2012
October 2016   (final data collection date for primary outcome measure)
  • Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Best corrected Snellen acuity
  • Keratometry measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Average curvature of the cornea
Same as current
Complete list of historical versions of study NCT01708538 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Corneal Collagen Cross-linking
Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Corneal Ectasia Disorders Including Keratoconus
Drug: CXL
corneal crosslinking
  • Active Comparator: Epithelium on
    Epi not removed during CXL treatment
    Intervention: Drug: CXL
  • Active Comparator: Epithelium off
    Epi removed before CXL treatment
    Intervention: Drug: CXL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 10-70, willing to participate, diagnosis of corneal ectasia disorder

Exclusion Criteria:

  • Unwilling or unable to participate in trial
Both
10 Years to 70 Years
No
Contact: Sloan W Rush, MD 806-353-0125
United States
 
NCT01708538
Rush CXL
Yes
Rush Eye Associates
Rush Eye Associates
Not Provided
Not Provided
Rush Eye Associates
November 2014

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