Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
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|ClinicalTrials.gov Identifier: NCT01181219|
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : December 12, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Procedure: CXL without epithelial removal Procedure: CXL with epithelial removal||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning|
|Study Start Date :||July 2010|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Experimental: CXL without epithelial removal
Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium
Procedure: CXL without epithelial removal
UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
Active Comparator: CXL with epithelial removal
Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation
Procedure: CXL with epithelial removal
UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed
- Best corrected distant visual acuity (BCDVA) [ Time Frame: One year ]
- Corneal topographic keratoconus features [ Time Frame: One year ]Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181219
|University Hospital North Norway|
|Tromsoe, Troms, Norway, 9000|
|Principal Investigator:||Aleksandar Stojanovic, MD||University Hospital North Norway|