Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT06921967

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

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of keratoconus
  • Best spectacle corrected visual acuity better than 0.00 logMAR
  • Age between 18 and 40 years
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

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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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