NCT02349165

Standard Versus Transepithelial Corneal Crosslinking

Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Nienke Soeters · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Transepithelial versus epithelium-off CXL	A comparison of the CXL procedure with and without epithelium removal
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2015-01-28
• Last updated: 2015-01-28

Locations

1 site across 1 country: Netherlands