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Standard Versus Transepithelial Corneal Crosslinking

NCT02349165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-01-28

No results posted yet for this study

Summary

The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.

Conditions

  • Keratoconus

Interventions

PROCEDURE

Transepithelial versus epithelium-off CXL

A comparison of the CXL procedure with and without epithelium removal

DRUG

Ricrolin TE

Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation

DRUG

Isotonic riboflavin

After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation

Sponsors & Collaborators

  • Dr. F.P. Fischer Stichting

    collaborator UNKNOWN

  • Stichting Nederlands Oogheelkundig Onderzoek

    collaborator UNKNOWN

  • Nienke Soeters

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Netherlands

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 NCT02349165 on ClinicalTrials.gov