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

Recruiting now · Not applicable

Conditions studied: Keratoconus, Irregular Astigmatism

In brief

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.

Key facts

Study ID

NCT06921967

Run by

University of Aarhus

People needed

50

Starts

2025-08-15

Expected to finish

2028-02-29

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Keratoconus, best spectacle corrected visual acuity >0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40

You may not qualify if…

• K-max >60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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