Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus

Condition(s) studied

Investigational drug(s) / intervention(s)

Rose K2: Corneal RGP lens with flexible parameters.

Onefit MED: Scleral RGP lens with flexible parameters.

Study 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

Primary outcome measure(s)

• Visual Acuity — 6 weeks with each intervention. 13 weeks total, incl. 1 week washout.
  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.

Trial sites (1)

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