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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03598634

Enrollment

Registered

2018-07-26

Start date

2014-06-01

Completion date

2017-12-31

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

cross-linking

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.

Interventions

PROCEDUREadministration of riboflavin for epi-off cross-linking

riboflavin 0.1% in 20% dextran solution

PROCEDUREadministration of riboflavin for epi-on cross-linking

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Best-corrected visual acuity after treatment	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026