Keratoconus Clinical Trial
Official title:
Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning
Transepithelial CXL (performed without epithelial removal) seem to have similar clinical
effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal).
The current study attempts to prove that hypothesis.
A prospective, controlled, randomized, contralateral trial, will involve one eye of the
patient to be treated with transepithelial CXL, while the control eye will be treated with
the standard CXL. Totally 20 patients (age >18 and <40 years) referred by an ophthalmologist
to the eye department of the University Hospital North Norway for CXL treatment of bilateral
progressive keratoconus, will be recruited.
CXL appears to hinder the development of keratoconus by strengthening the cross-bindings in the corneal stroma with a resultant increase in corneal biomechanical strength of up to 300%. The method was introduced in the mid-nineties and has been approved for use in the EU countries since 2007. Standard treatment protocol, involving the removal of the corneal epithelium before the Riboflavin application, has been used. In order to avoid potential complications following removal of the epithelium (infection, delayed healing, scar formation, as well as discomfort and pain), a modified procedure where the epithelium is kept intact, so called transepithelial CXL, has been suggested. According to the preliminary results of the published retrospective studies, no significant difference in the clinical effect between the standard CXL with epithelial removal and the transepithelial CXL was found. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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