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Completed

NCT Number: NCT03598634

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

administration of riboflavin for epi-off cross-linking

Procedure

riboflavin 0.1% in 20% dextran solution

administration of riboflavin for epi-on cross-linking

Procedure

riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid

Primary outcomes

  1. Best-corrected visual acuity after treatment

    Time frame: up to 48 months from the recruitment

    • 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

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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