Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Clinical stabilisation of keratoconus one year after CXL
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
- •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.
Arms & Interventions
epithelium off CXL
epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
Intervention: Transepithelial versus epithelium-off CXL (Procedure)
epithelium off CXL
epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes)
Intervention: Isotonic riboflavin (Drug)
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).
Intervention: Transepithelial versus epithelium-off CXL (Procedure)
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).
Intervention: Ricrolin TE (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Complications, defined as epithelial healing problems and/or keratitis.(1 year)
Investigators
Nienke Soeters
BOptom
UMC Utrecht