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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXL without epithelial removal | Experimental | Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium |
|
| CXL with epithelial removal | Active Comparator | Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXL without epithelial removal | Procedure | UV-radiation of a Riboflavin saturated cornea without prior epithelial removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected distant visual acuity (BCDVA) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal topographic keratoconus features | Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness). | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandar Stojanovic, MD | University Hospital North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital North Norway | Tromsø | Troms | 9000 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25050368 | Derived | Stojanovic A, Zhou W, Utheim TP. Corneal collagen cross-linking with and without epithelial removal: a contralateral study with 0.5% hypotonic riboflavin solution. Biomed Res Int. 2014;2014:619398. doi: 10.1155/2014/619398. Epub 2014 Jun 22. |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| CXL with epithelial removal | Procedure | UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed |
|