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Standard Versus Transepithelial Corneal Crosslinking

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Transepithelial versus epithelium-off CXL
Ricrolin TE
Isotonic riboflavin
Sponsored by
Nienke Soeters
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

epithelium off CXL

Ricrolin TE CXL

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications, defined as epithelial healing problems and/or keratitis.
the incidence of epithelial healing problems after treatment will be recorded

Full Information

First Posted
January 17, 2015
Last Updated
January 27, 2015
Sponsor
Nienke Soeters
Collaborators
Dr. F.P. Fischer Stichting, Stichting Nederlands Oogheelkundig Onderzoek
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1. Study Identification

Unique Protocol Identification Number
NCT02349165
Brief Title
Standard Versus Transepithelial Corneal Crosslinking
Official Title
Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nienke Soeters
Collaborators
Dr. F.P. Fischer Stichting, Stichting Nederlands Oogheelkundig Onderzoek

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epithelium off CXL
Arm Type
Active Comparator
Arm Description
epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
Arm Title
Ricrolin TE CXL
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Transepithelial versus epithelium-off CXL
Other Intervention Name(s)
epithelium-on versus epithelium-ff corneal crosslinking
Intervention Description
A comparison of the CXL procedure with and without epithelium removal
Intervention Type
Drug
Intervention Name(s)
Ricrolin TE
Intervention Description
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
Intervention Type
Drug
Intervention Name(s)
Isotonic riboflavin
Intervention Description
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
Primary Outcome Measure Information:
Title
Clinical stabilisation of keratoconus one year after CXL
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications, defined as epithelial healing problems and/or keratitis.
Description
the incidence of epithelial healing problems after treatment will be recorded
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32557558
Citation
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Results Reference
derived

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Standard Versus Transepithelial Corneal Crosslinking

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