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The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Rush Eye Associates
Information provided by (Responsible Party):
Rush Eye Associates Identifier:
First received: October 15, 2012
Last updated: April 4, 2016
Last verified: April 2016
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
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 ]
    Best corrected Snellen acuity

  • Keratometry measurements [ Time Frame: 1 year ]
    Average curvature of the cornea

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: October 2016 (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


Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01708538

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rush Eye Associates Identifier: NCT01708538     History of Changes
Other Study ID Numbers: Rush CXL
Study First Received: October 15, 2012
Last Updated: April 4, 2016

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

Additional relevant MeSH terms:
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical processed this record on March 24, 2017