University Hospital North Norway
Tromsø, Troms, 9000, Norway
NCT Number: NCT01181219
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.
Looking for future studies?
Notify Me18 year–40 year
All sexes
Interventional
Phase 2
Tromsø, Troms, 9000, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed
Time frame: One year
Time frame: One year
Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).
University Hospital of North Norway
Other
Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06818461
Corneal Diseases, Eye Diseases
Mohandessin, Giza Governorate, Egypt
View Trial DetailsNCT06100939
Corneal Diseases, Eye Diseases
Rowland Heights, California, United States
View Trial DetailsNCT06100952
Corneal Diseases, Eye Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT04418999
Allergy, Corneal Diseases
Chicago, Illinois, United States
View Trial Details