Keratoconus Clinical Trial
Official title:
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.
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.
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