Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia (CL)
Primary Purpose
Progressive Keratoconus, Corneal Ectasia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Corneal collagen
Sham comparator
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 the keratoconus group
- Corneal scarring
Sites / Locations
- Woolfson Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control
Arm Description
Corneal collagen cross-linking
Sham Treatment
Outcomes
Primary Outcome Measures
Change in keratometry
Secondary Outcome Measures
Best spectacle-corrected visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567671
Brief Title
Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Acronym
CL
Official Title
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.
Detailed Description
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.
Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.
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
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Corneal collagen cross-linking
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham Treatment
Intervention Type
Procedure
Intervention Name(s)
Corneal collagen
Intervention Description
Corneal collagen cross-linking with riboflavin/UVA light
Intervention Type
Procedure
Intervention Name(s)
Sham comparator
Intervention Description
Sham treatment
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
14 Years
Accepts Healthy Volunteers
No
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 the keratoconus group
Corneal scarring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Doyle Stulting, MD, PhD
Organizational Affiliation
Emory Vision; Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woolfson Eye Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25365551
Citation
Hallahan KM, Rocha K, Roy AS, Randleman JB, Stulting RD, Dupps WJ Jr. Effects of corneal cross-linking on ocular response analyzer waveform-derived variables in keratoconus and postrefractive surgery ectasia. Eye Contact Lens. 2014 Nov;40(6):339-44. doi: 10.1097/ICL.0000000000000090.
Results Reference
derived
Links:
URL
http://www.emoryvision.com
Description
Click here to contact the investigator site for this study.
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Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
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