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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

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

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 50
Treatments
Active_comparator: Corneal Rigid Gas Permeable Contact Lens
Small diameter RGP lens (TD \< HVID).
Active_comparator: Scleral Rigid Gas Permeable Contact Lens
Large diameter RGP lens (TD\>HVID).
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov