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Standard Versus Transepithelial Corneal Crosslinking

Sponsor
Nienke Soeters (Other)
Overall Status
Completed
CT.gov ID
NCT02349165
Collaborator
Dr. F.P. Fischer Stichting (Other), Stichting Nederlands Oogheelkundig Onderzoek (Other)
61
Enrollment
1
Location
2
Arms
40
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transepithelial versus epithelium-off CXL
  • Drug: Ricrolin TE
  • Drug: Isotonic riboflavin
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: epithelium off CXL

epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)

Procedure: Transepithelial versus epithelium-off CXL
A comparison of the CXL procedure with and without epithelium removal
Other Names:
  • epithelium-on versus epithelium-ff corneal crosslinking

    • Drug: Isotonic riboflavin
    After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
    Experimental: Ricrolin TE CXL

    Ricrolin-TE eye drops for 15 minutes (2 minute interval) and 15 minute Ricrolin TE pooled on the cornea using a silicone ring + 30 minutes ultraviolet-A irradiation (Ricrolin TE every 5 minutes).

    Procedure: Transepithelial versus epithelium-off CXL
    A comparison of the CXL procedure with and without epithelium removal
    Other Names:
  • epithelium-on versus epithelium-ff corneal crosslinking

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

    Outcome Measures

    Primary Outcome Measures

    1. Clinical stabilisation of keratoconus one year after CXL [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 Outcome Measures

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

      the incidence of epithelial healing problems after treatment will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Utrecht Utrecht Netherlands 3584 CX

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nienke Soeters, BOptom, UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT02349165
    Other Study ID Numbers:
    • NL29961
    • 10-374
    First Posted:
    Jan 28, 2015
    Last Update Posted:
    Jan 28, 2015
    Last Verified:
    Jan 1, 2015
    Additional relevant MeSH terms:
    Keratoconus
    Riboflavin

    Study Results

    No Results Posted as of Jan 28, 2015