Back to resultsCorneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)
Primary Purpose
Progressive Keratoconus, Corneal Ectasia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Riboflavin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Keratoconus focused on measuring keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
Eligibility 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
Sites / Locations
- The Ohio State University Medical Center
- OSU Havener Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham treatment
Treatment Arm
Arm Description
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.
After randomization, the active arm will have the collagen crosslinking intervention.
Outcomes
Primary Outcome Measures
change in keratometry
Secondary Outcome Measures
best spectacle-corrected visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00679666
Brief Title
Corneal Crosslinking in Keratoconus and Corneal Ectasia
Acronym
CXL
Official Title
Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator no longer at university
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Keratoconus, Corneal Ectasia
Keywords
keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
After randomization, the active arm will have the collagen crosslinking intervention.
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Other Intervention Name(s)
Vitamin B2
Intervention Description
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in keratometry
Time Frame
3 months
Secondary Outcome Measure Information:
Title
best spectacle-corrected visual acuity
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Keates, MD
Organizational Affiliation
The Ohio State Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OSU Havener Eye Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Corneal Crosslinking in Keratoconus and Corneal Ectasia
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