Standard Versus Transepithelial Corneal Crosslinking
- Conditions
- Keratoconus
- Interventions
- Registration Number
- NCT02349165
- Lead Sponsor
- Nienke Soeters
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description epithelium off CXL Isotonic riboflavin epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes) Ricrolin TE CXL Transepithelial versus epithelium-off 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). Ricrolin TE CXL Ricrolin TE 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). epithelium off CXL Transepithelial versus epithelium-off CXL epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
- Primary Outcome Measures
Name Time Method 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
Name Time Method Complications, defined as epithelial healing problems and/or keratitis. 1 year the incidence of epithelial healing problems after treatment will be recorded
Trial Locations
- Locations (1)
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands