Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
administration of riboflavin for epi-off cross-linking
administration of riboflavin for epi-on cross-linking
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring cross-linking
Eligibility Criteria
Inclusion Criteria:
- patients with evolving keratoconus
- aged between 18 and 40 years
- no evidence of corneal scarring
Exclusion Criteria:
- patients with central and paracentral corneal opacities
- Vogt's striae
- previous intraocular surgery
- history of herpetic keratitis
- history of severe dry eye
- concomitant autoimmune diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epi-on cross-linking
Epi-off cross-linking
Arm Description
Intervention: Drug: Riboflavin 0.15 in 20% dextran solution
intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid
Outcomes
Primary Outcome Measures
Best-corrected visual acuity after treatment
Scale name: Early treatment diabetic retinopathy study (ETDRS) charts.
Scale range 0-1.
highest value of the range (corresponding to 20/20): 0
lowest value of the range (corresponding to 20/200): 1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03598634
Brief Title
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
Official Title
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Molise
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Detailed Description
The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
cross-linking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epi-on cross-linking
Arm Type
Active Comparator
Arm Description
Intervention: Drug: Riboflavin 0.15 in 20% dextran solution
Arm Title
Epi-off cross-linking
Arm Type
Active Comparator
Arm Description
intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid
Intervention Type
Procedure
Intervention Name(s)
administration of riboflavin for epi-off cross-linking
Intervention Description
riboflavin 0.1% in 20% dextran solution
Intervention Type
Procedure
Intervention Name(s)
administration of riboflavin for epi-on cross-linking
Intervention Description
riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
Primary Outcome Measure Information:
Title
Best-corrected visual acuity after treatment
Description
Scale name: Early treatment diabetic retinopathy study (ETDRS) charts.
Scale range 0-1.
highest value of the range (corresponding to 20/20): 0
lowest value of the range (corresponding to 20/200): 1
Time Frame
up to 48 months from the recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with evolving keratoconus
aged between 18 and 40 years
no evidence of corneal scarring
Exclusion Criteria:
patients with central and paracentral corneal opacities
Vogt's striae
previous intraocular surgery
history of herpetic keratitis
history of severe dry eye
concomitant autoimmune diseases.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be made available once the studies results will be published
Learn more about this trial
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
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