Back to resultsThe Effects of Corneal Collagen Cross-linking
Primary Purpose
Corneal Ectasia Disorders Including Keratoconus
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CXL
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Ectasia Disorders Including Keratoconus focused on measuring keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
Eligibility Criteria
Inclusion Criteria:
- Age 10-70, willing to participate, diagnosis of corneal ectasia disorder
Exclusion Criteria:
- Unwilling or unable to participate in trial
Sites / Locations
- Rush Eye AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epithelium on
Epithelium off
Arm Description
Epi not removed during CXL treatment
Epi removed before CXL treatment
Outcomes
Primary Outcome Measures
Visual acuity
Best corrected Snellen acuity
Keratometry measurements
Average curvature of the cornea
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708538
Brief Title
The Effects of Corneal Collagen Cross-linking
Official Title
Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush Eye Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ectasia Disorders Including Keratoconus
Keywords
keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epithelium on
Arm Type
Active Comparator
Arm Description
Epi not removed during CXL treatment
Arm Title
Epithelium off
Arm Type
Active Comparator
Arm Description
Epi removed before CXL treatment
Intervention Type
Drug
Intervention Name(s)
CXL
Intervention Description
corneal crosslinking
Primary Outcome Measure Information:
Title
Visual acuity
Description
Best corrected Snellen acuity
Time Frame
1 year
Title
Keratometry measurements
Description
Average curvature of the cornea
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 10-70, willing to participate, diagnosis of corneal ectasia disorder
Exclusion Criteria:
Unwilling or unable to participate in trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sloan W Rush, MD
Phone
806-353-0125
Facility Information:
Facility Name
Rush Eye Associates
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunday Fowler
Phone
806-353-0125
First Name & Middle Initial & Last Name & Degree
Sloan W Rush, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
27388250
Citation
Rush SW, Rush RB. Epithelium-off versus transepithelial corneal collagen crosslinking for progressive corneal ectasia: a randomised and controlled trial. Br J Ophthalmol. 2017 Apr;101(4):503-508. doi: 10.1136/bjophthalmol-2016-308914. Epub 2016 Jul 7.
Results Reference
derived
Learn more about this trial
The Effects of Corneal Collagen Cross-linking
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