Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Aarhus
About this trial
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
This trial does not accept healthy volunteersQualifiers
Keratoconus, best spectacle corrected visual acuity >0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40
Disqualifiers
K-max >60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history
Trial design
Design model
Crossover
Treatments tested in this trial
Rose K2
DeviceCorneal RGP lens with flexible parameters.
Onefit MED
DeviceScleral RGP lens with flexible parameters.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Corneal Rigid Gas Permeable Contact LensActive comparator 1 intervention
Group B: Scleral Rigid Gas Permeable Contact LensActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Acuity
Comparison of Best Corrected Visual Acuity, with the two interventions, at the end of 6 weeks of lens wear. Measured with ETDRS charts, converted to logMAR units.
Time frame
6 weeks with each intervention. 13 weeks total, incl. 1 week washout.Secondary outcomes
1
Contrast Sensitivity
Comparision of contrast sensitivity with the two interventions, measured with a Pelli Robson Chart.
Time frame
6 weeks with each intervention. 13 weeks total, incl. 1 week washout.2
Higher Order Aberrations (HOA)
Comparison of HOA with the two interventions at the end of 6 weeks of lens wear. Measured with the Visual Adaptive Optics Simulator by Voptica. Root Mean Square value in microns.
Time frame
6 weeks with each intervention. 13 weeks total, incl. 1 week washout.3
Tear break-up time (TBUT)
Comparison of Tear break-up time with the two interventions at the end of 6 weeks of lens wear. Using fluorescein and slit lamp to capture the break-up time in seconds.
Time frame
6 weeks with each intervention. 13 weeks total, incl. 1 week washout.4
Anterior ocular health markers
Comparison of anterior ocular health with the two interventions at the end of 6 weeks of lens wear. Using fluorescein and slit lamp to grade with the Efron Grading Scale. Scored on a scale from 0 to 4 with higher values representing worse outcomes.
Time frame
6 weeks with each intervention. 13 weeks total, incl. 1 week washout.Sponsors and contacts
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov