About this trial
This study aims to compare the ocular health and visual quality of corneal rigid gas permeable lenses (CRGPL) and scleral rigid gas permeable lenses (SRGPL) for patients with keratoconus in a crossover clinical trial. The study will analyze subjective and objective outcomes, including best corrected visual acuity, contrast sensitivity, higher-order aberrations and subjective perception of visual function and comfort. It will also investigate the impact of both lens types on the health of the ocular surface, including evaluation of corneal, conjunctival, and scleral tissues, and tear film. Only one randomized controlled trial has compared the effect of CRGPL and SRGPL wear for patients with an ectatic corneal disorder. With the increasing popularity of SRGPL, examining the differences in efficacy, safety, and patient-reported outcomes between the two types of lenses is increasingly relevant.
Eligibility criteria
Qualifiers
Keratoconus, best spectacle corrected visual acuity >0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40
Disqualifiers
K-max >60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history
Trial design
Treatments tested in this trial
- Rose K2
- Onefit MED
Treatment groups
Locations
1Sponsors and collaborators
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator