Corneal versus scleral rigid gas permeable lenses for keratoconus
A Comparison of Ocular Health and Visual Quality With Corneal and Scleral Rigid Gas Permeable Lenses in Keratoconus Patients
NA · University of Aarhus · NCT06921967
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06921967 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratoconus, Irregular Astigmatism, Contact Lenses, Scleral Lenses, Corneal Lenses, Rigid gas permeable lenses, Rigid lenses, GP lenses