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Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)

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ClinicalTrials.gov Identifier: NCT00679666
Recruitment Status : Withdrawn (Investigator no longer at university)
First Posted : May 19, 2008
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Brief Summary:
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

Condition or disease Intervention/treatment Phase
Progressive Keratoconus Corneal Ectasia Drug: Riboflavin Drug: Placebo Phase 2 Phase 3

Detailed Description:
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham treatment
Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.
Drug: Placebo
Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
Active Comparator: Treatment Arm
After randomization, the active arm will have the collagen crosslinking intervention.
Drug: Riboflavin
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
Other Name: Vitamin B2



Primary Outcome Measures :
  1. change in keratometry [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. best spectacle-corrected visual acuity [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of keratoconus with documented progression over the previous 12 months.
  • Diagnosis of corneal ectasia
  • Must be able to complete all study visits.

Exclusion Criteria:

  • Prior corneal surgery in keratoconus group
  • Corneal scarring
  • Pregnancy

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): NCT00679666


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
OSU Havener Eye Institute
Dublin, Ohio, United States, 43016
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Richard Keates, MD The Ohio State Univesity

Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT00679666     History of Changes
Other Study ID Numbers: 2008H0050,2008H0049
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Ohio State University:
keratoconus
ectasia
cross-linking
riboflavin
UVA light
cornea

Additional relevant MeSH terms:
Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents