Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus

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.

NCT Number	NCT06921967
Lead Sponsor	University of Aarhus Collaborators: Aarhus University Hospital
Conditions	Keratoconus, Irregular Astigmatism
Enrollment	50 participants
Start Date	2025-08-15
Primary Completion	2027-09 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2025-08-24