The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants. (see Contacts and Locations)
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
  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.

Resource links provided by NLM:


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
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: 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 August 28, 2014