Actively Recruiting
Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
Led by University of Aarhus · Updated on 2025-08-24
50
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of keratoconus
- Best spectacle corrected visual acuity better than 0.00 logMAR
- Age between 18 and 40 years
You will not qualify if you...
- Maximum corneal curvature (K-max) greater than 60 diopters
- Wearing rigid gas permeable lenses at the start of the study
- Presence of ocular surface disease confirmed by exam and patient history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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