Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus

Keratoconus Clinical Trial

Official title:

Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181219
• Other study ID #: CXL-TE UNN2010
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2010
• Last updated: December 11, 2014
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (BSCVA) and/or increase in cornea curvature or asymmetry

• Corneal thickness =400µm at the thinnest point

• Age range from 18 to 40

• Amsler-Krumeich classification graded stage I to III

Exclusion Criteria:

• Corneal thickness <400µm at the thinnest point

• History of viral keratitis

• Severe dry eye

• Concurrent corneal infections

• Previous ocular surgery

• Hard contact lens wear for =4 weeks before baseline examination

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• CXL without epithelial removal
UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
• CXL with epithelial removal
UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed

Locations

Country	Name	City	State
Norway	University Hospital North Norway	Tromsoe	Troms

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected distant visual acuity (BCDVA)		One year	Yes
Secondary	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	Yes