- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349165
Standard Versus Transepithelial Corneal Crosslinking
Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
A comparison of the CXL procedure with and without epithelium removal
Other Names:
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).
|
A comparison of the CXL procedure with and without epithelium removal
Other Names:
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications, defined as epithelial healing problems and/or keratitis.
Time Frame: 1 year
|
the incidence of epithelial healing problems after treatment will be recorded
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL29961
- 10-374 (Registry Identifier: METC UMC Utrecht)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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