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The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants.
Verified April 2017 by Rush Eye Associates
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708538
First Posted: October 17, 2012
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rush Eye Associates
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rush Eye Associates
ClinicalTrials.gov Identifier: NCT01708538     History of Changes
Other Study ID Numbers: Rush CXL
First Submitted: October 15, 2012
First Posted: October 17, 2012
Last Update Posted: April 12, 2017
Last Verified: April 2017

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

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