Corneal versus scleral rigid gas permeable lenses for keratoconus
Official title: A Comparison of Ocular Health and Visual Quality With Corneal and Scleral Rigid Gas Permeable Lenses in Keratoconus Patients
Run by University of Aarhus · NCT06921967 · Data updated 2026-11-12
This trial tests corneal versus scleral rigid gas permeable lenses in adults with keratoconus to see which lens type gives better vision and comfort.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | September 2027 |
| Study ends | February 29, 2028 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT06921967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–40 with keratoconus who meet the trial's visual and ocular-surface criteria and are not current rigid contact lens wearers.
✕Probably not a fit
Patients with very advanced disease (K-max >60 D), active ocular surface disease, current RGP lens wearers, or those outside the 18–40 age range are unlikely to be eligible or to benefit from the comparisons made in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized crossover trial compares corneal rigid gas permeable (CRGPL) lenses (Rose K2) and scleral rigid gas permeable (SRGPL) lenses (Onefit MED) in adults with keratoconus. It measures objective outcomes such as best-corrected visual acuity, contrast sensitivity, and higher-order aberrations alongside subjective perception of visual function and comfort. The study also examines ocular surface health by evaluating corneal, conjunctival, and scleral tissues and performing tear film analysis. Each participant will be fitted and will wear both lens types in randomized order with clinical assessments at each stage.
Why it matters
Potential benefit: If successful, the results could help people with keratoconus choose the lens type that provides better vision and comfort while reducing ocular-surface problems.
How similar studies have gone: Randomized evidence is limited—only one prior RCT compared corneal and scleral RGP lenses in ectatic corneas—though observational studies and clinical experience suggest scleral lenses often improve comfort and optics for many patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Aarhus University Hospital
Aarhus, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.