Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06921967
NA

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

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-15

Completion Date

2028-02-29

Last Updated

2025-08-24

Healthy Volunteers

No

Interventions

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