Title
Standard Versus Transepithelial Corneal Crosslinking
Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Phase
N/ALead Sponsor
UMC UtrechtStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
KeratoconusIntervention/Treatment
ricrolin riboflavin ...Study Participants
61The 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.
A comparison of the CXL procedure with and without epithelium removal
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
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.
