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Completed

NCT Number: NCT02349165

Standard Versus Transepithelial Corneal Crosslinking

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented progressive KC (by Pentacam and/or corneal topography imaging).
  • A clear central cornea.
  • A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
  • Minimal Snellen corrected distance visual acuity of ≥ 0.4.
  • Patient age of ≥ 18 years.

For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:

  • Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:

o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry

  • Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months

Exclusion criteria

  • Presence of corneal scars.
  • History of epithelial healing problems.
  • Presence of previous ocular infection (such as herpes keratitis).
  • Patients who are pregnant and/or breastfeeding.

Treatment and study plan

Transepithelial versus epithelium-off CXL

Procedure

A comparison of the CXL procedure with and without epithelium removal

Other names: epithelium-on versus epithelium-ff corneal crosslinking

Ricrolin TE

Drug

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

Isotonic riboflavin

Drug

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

Primary outcomes

  1. Clinical stabilisation of keratoconus one year after CXL

    Time frame: 1 year

    Using a Scheimpflug device (Pentacam, Oculus), topography measurements are performed. Clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value.

Secondary outcomes

  1. Complications, defined as epithelial healing problems and/or keratitis.

    Time frame: 1 year

    the incidence of epithelial healing problems after treatment will be recorded

Sponsors and collaborators

Lead sponsor

Nienke Soeters

Other

Collaborators

  • Dr. F.P. Fischer Stichting
  • Stichting Nederlands Oogheelkundig Onderzoek

Registry information

Official study title

Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2015
Registry last updated
Jan 28, 2015

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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