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Completed

NCT Number: NCT01181219

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital North Norway

Tromsø, Troms, 9000, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CXL without epithelial removal

Procedure

UV-radiation of a Riboflavin saturated cornea without prior epithelial removal

CXL with epithelial removal

Procedure

UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed

Primary outcomes

  1. Best corrected distant visual acuity (BCDVA)

    Time frame: One year

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2010
Registry last updated
Dec 12, 2014

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.

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