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

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

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Procedure: administration of riboflavin for epi-off cross-linking; Procedure: administration of riboflavin for epi-on cross-linking

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Molise

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: July 14, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 14, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: cross-linking
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: 0001-05-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data will be made available once the studies results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No