Standard Versus Transepithelial Corneal Crosslinking

Keratoconus Clinical Trial

Official title:

Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349165
• Other study ID #: NL29961
• Secondary ID: 10-374
• Status: Completed
• Phase: N/A
• First received: January 17, 2015
• Last updated: January 27, 2015
• Start date: May 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Ministry of Health, Welfare and SportNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Nienke Soeters	Dr. F.P. Fischer Stichting, Stichting Nederlands Oogheelkundig Onderzoek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical stabilisation of keratoconus one year after CXL	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.	1 year	Yes
Secondary	Complications, defined as epithelial healing problems and/or keratitis.	the incidence of epithelial healing problems after treatment will be recorded	1 year	No