To evaluate the role of the epithelium in the effect of CXL for treatment of progressive KC and to determine whether the epithelium should be removed or can be left intact during treatment.
ID
Source
Brief title
Condition
- Eye disorders congenital
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the keratometry outcome over a period of 1 year,
which is measured by corneal topography and Pentacam imaging.
Secondary outcome
The secondary objective is the incidence of epithelial healing problems after
treatment.
Background 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. We expect to achieve a similar effect of
TE-CXL with the advantage of a faster healing time and less risk of infections.
Study objective
To evaluate the role of the epithelium in the effect of CXL for treatment of
progressive KC and to determine whether the epithelium should be removed or can
be left intact during treatment.
Study design
Randomized clinical trial
Intervention
CXL is performed on all patients included in the study. Patients will be
divided at random into two groups. Group 1 will undergo standard CXL treatment
with the initial step of epithelial removal prior to application of riboflavin
drops (3-minute intervals over a 30-minute period). Group 2 will undergo TE-CXL
treatment, whereby the epithelium is left intact and alternate riboflavin drops
will be applied (Ricrolin TE)
Study burden and risks
The treatment that will be investigated in this study consists of a
semi-invasive procedure, whereby 2 components will be altered from the gold
standard procedure. The gold standard CXL procedure involves the initial
removal of the epithelium before riboflavin application. Studies in the
literature state that the advantage of this initial step of epithelial removal
is a better penetration of riboflavin solution through the corneal stroma.
However, this initial step also poses the patient at a higher risk for post-CXL
infections and epithelial healing problems. In contrast, the alternative TE-CXL
procedures that will be investigated in this study are less invasive in nature,
since they skip the initial step of epithelial removal. This could of benefit
to the patient, since the risk of infection is believed to be less.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Patient age of >= 18 years, documented progressive KC (by Pentacam and/or corneal topography imaging), a clear central cornea, minimal corneal thickness of at the thinnest corneal location (Pentacam imaging), minimal Snellen corrected distance visual acuity of >= 0.4.
Exclusion criteria
Patient age less than 18 years, stable keratometry values over time, presence of corneal scar(s)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29961.041.10 |