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

NCT01181219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-12-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Aleksandar Stojanovic, MD · University Hospital North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181219 on ClinicalTrials.gov