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RECRUITINGINTERVENTIONAL

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

A Comparison of Ocular Health and Visual Quality With Corneal and Scleral Rigid Gas Permeable Lenses in Keratoconus Patients

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Keratoconus, best spectacle corrected visual acuity \>0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40 Who Should NOT Join This Trial: - K-max \>60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Keratoconus, best spectacle corrected visual acuity \>0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40 Exclusion Criteria: * K-max \>60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history

Treatments Being Tested

DEVICE

Rose K2

Corneal RGP lens with flexible parameters.

DEVICE

Onefit MED

Scleral RGP lens with flexible parameters.

Locations (1)

Aarhus University Hospital
Aarhus, Denmark