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

NCT01181219 | Completed Phase 2

• 1 other identifier: CXL-TE UNN2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Best corrected distant visual acuity (BCDVA)

  One year

Secondary Outcomes (1)

• Corneal topographic keratoconus features

  One year

Study Arms (2)

CXL without epithelial removal

EXPERIMENTAL

Application of Riboflavin and the consequent UV-irradiation with intact corneal epithelium

Procedure: CXL without epithelial removal

CXL with epithelial removal

ACTIVE COMPARATOR

Corneal epithelial removal prior to Riboflavin and the consequent UV-irradiation

Procedure: CXL with epithelial removal

Interventions

CXL without epithelial removal PROCEDURE

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

CXL without epithelial removal

CXL with epithelial removal PROCEDURE

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

CXL with epithelial removal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital North Norway

Tromsø, Troms, 9000, Norway

Location

Related Publications (1)

• 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.

  PMID: 25050368 DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Aleksandar Stojanovic, MD

  University Hospital North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2012-05

Locations

NO (1)