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The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants.
Verified October 2012 by Rush Eye Associates
Sponsor:
Information provided by (Responsible Party):
Rush Eye Associates
ClinicalTrials.gov Identifier:
NCT01708538
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Corneal Ectasia Disorders Including Keratoconus
 Drug: CXL
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.

Further study details as provided by Rush Eye Associates:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epithelium on
Epi not removed during CXL treatment
 Drug: CXL
corneal crosslinking
Active Comparator: Epithelium off
Epi removed before CXL treatment
 Drug: CXL
corneal crosslinking

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwilling or unable to participate in trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708538

Contacts
Contact: Sloan W Rush, MD 806-353-0125

Locations
United States, Texas
Rush Eye Associates Recruiting
Amarillo, Texas, United States, 79106
Contact: Sunday Fowler     806-353-0125        
Principal Investigator: Sloan W Rush, MD            
Sponsors and Collaborators
Rush Eye Associates
  More Information

No publications provided

Responsible Party: Rush Eye Associates
ClinicalTrials.gov Identifier: NCT01708538     History of Changes
Other Study ID Numbers: Rush CXL
Study First Received: October 15, 2012
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush Eye Associates:
keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia

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

ClinicalTrials.gov processed this record on May 16, 2013