Standard Versus Transepithelial Corneal Crosslinking
Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
  • Phase

  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ricrolin riboflavin ...
  • Study Participants

The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.
Study Started
May 31
Primary Completion
Sep 30
Study Completion
Sep 30
Last Update
Jan 28

Procedure Transepithelial versus epithelium-off CXL

A comparison of the CXL procedure with and without epithelium removal

  • Other names: epithelium-on versus epithelium-ff corneal crosslinking

Drug Ricrolin TE

Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation

Drug Isotonic riboflavin

After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation

epithelium off CXL Active Comparator

epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)

Ricrolin TE CXL Experimental

Ricrolin-TE eye drops for 15 minutes (2 minute interval) and 15 minute Ricrolin TE pooled on the cornea using a silicone ring + 30 minutes ultraviolet-A irradiation (Ricrolin TE every 5 minutes).


Inclusion Criteria:

Documented progressive KC (by Pentacam and/or corneal topography imaging).
A clear central cornea.
A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
Minimal Snellen corrected distance visual acuity of ≥ 0.4.
Patient age of ≥ 18 years.

For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:

Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:

o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry

Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months

Exclusion Criteria:

Presence of corneal scars.
History of epithelial healing problems.
Presence of previous ocular infection (such as herpes keratitis).
Patients who are pregnant and/or breastfeeding.
No Results Posted