Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up

Conditions
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Keratoconus

Intervention / Treatment
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* Procedure: administration of riboflavin for epi-off cross-linking
* Procedure: administration of riboflavin for epi-on cross-linking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epi-on cross-linking<br>Intervention: Drug: Riboflavin 0.15 in 20% dextran solution | Procedure: administration of riboflavin for epi-off cross-linking<br>* riboflavin 0.1% in 20% dextran solution<br>Procedure: administration of riboflavin for epi-on cross-linking<br>* riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid<br>|
| Active Comparator: Epi-off cross-linking<br>intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid | Procedure: administration of riboflavin for epi-off cross-linking<br>* riboflavin 0.1% in 20% dextran solution<br>Procedure: administration of riboflavin for epi-on cross-linking<br>* riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 48 months from the recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cross-linking