NCT06921967 Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
| NCT ID | NCT06921967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-15 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06921967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921967 currently recruiting?
Yes, NCT06921967 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Aarhus to inquire about joining.
Where is the NCT06921967 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06921967 clinical trial?
NCT06921967 is sponsored by University of Aarhus. The trial plans to enroll 50 participants.