Keratoconus
Conditions
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.
Interventions
PROCEDURETransepithelial versus epithelium-off CXL
A comparison of the CXL procedure with and without epithelium removal
DRUGRicrolin TE
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
Sponsors
Dr. F.P. Fischer Stichting
Stichting Nederlands Oogheelkundig Onderzoek
Nienke Soeters
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complications, defined as epithelial healing problems and/or keratitis. | 1 year | the incidence of epithelial healing problems after treatment will be recorded |
Countries
Netherlands
Outcome results
None listed