Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)

This study has been withdrawn prior to enrollment.
(Investigator no longer at university)
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00679666
First received: April 2, 2008
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Progressive Keratoconus
Corneal Ectasia
Drug: Riboflavin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • change in keratometry [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • best spectacle-corrected visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 207
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Richard H. Keates,MD Emeritus Professor of Ophthalmology, Dept of Ophthalmology,The Ohio State University
ClinicalTrials.gov Identifier: NCT00679666     History of Changes
Other Study ID Numbers: 2008H0050,2008H0049
Study First Received: April 2, 2008
Last Updated: July 29, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014