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

University of Molise

Status: Completed

Conditions: Keratoconus

Treatments: Procedure: administration of riboflavin for epi-on cross-linking; Procedure: administration of riboflavin for epi-off cross-linking

Study type: Interventional

Funder types: Other

Identifiers

NCT03598634

0001-05-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Epi-on cross-linking

Active Comparator group

Description:

Intervention: Drug: Riboflavin 0.15 in 20% dextran solution

Treatment:

Procedure: administration of riboflavin for epi-off cross-linking

Procedure: administration of riboflavin for epi-on cross-linking

Epi-off cross-linking

Active Comparator group

Description:

intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid

Treatment:

Procedure: administration of riboflavin for epi-off cross-linking

Procedure: administration of riboflavin for epi-on cross-linking