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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01181219
First received: August 12, 2010
Last updated: May 30, 2012
Last verified: May 2012

August 12, 2010
May 30, 2012
July 2010
May 2012   (final data collection date for primary outcome measure)
Best corrected distant visual acuity (BCDVA) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01181219 on ClinicalTrials.gov Archive Site
Corneal topographic keratoconus features [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Corneal topographic features (and indices) showing keratectatic development will be followed (K-values, optical asymmetry, posterior surface protrusion and thickness).
Same as current
Not Provided
Not Provided
 
Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Keratoconus
  • Procedure: CXL without epithelial removal
    UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
  • Procedure: CXL with epithelial removal
    UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed
  • Experimental: CXL without epithelial removal
    Intervention: Procedure: CXL without epithelial removal
  • Active Comparator: CXL with epithelial removal
    Intervention: Procedure: CXL with epithelial removal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
May 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01181219
CXL-TE UNN2010
No
University Hospital of North Norway
University Hospital of North Norway
Not Provided
Principal Investigator: Aleksandar Stojanovic, MD University Hospital North Norway
University Hospital of North Norway
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP