Clinical Trial: Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional




Official Title: A Randomised Controlled Research to Asses the Clinical Performance and Effect on Vision Related Quality of Life of Rigid Gas Permeable Scleral Versus Corneal Contact Lenses for Keratoconus and Other I

Brief Summary:

The most common causes for irregular cornea (IC) in hospital contact lens practice are Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to marked impairment of vision and cannot be effectively corrected by spectacles and soft contact lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable contact lenses (corneal lenses), which correct approximately 90% of the corneal irregularity.

Compared with a normal cornea, the cornea in KC is irregular and this results in a compromise to the fit of rigid corneal lenses. Specifically, they bear on the cornea and this, together with the vulnerability of the cornea in KC, are implicated in corneal scarring, and disease progression as well as a significantly reduced vision related quality of life (QoL) in KC compared with corneal lens wearers who have no KC.

In cases where the compromise fit of corneal lenses proves problematic, large diameter Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over the cornea and bear on the sclera.

The aim of this research is to investigate the performance of scleral lenses in KC participants who habitually wear corneal lenses.

The research question: is there a measurable difference in the visual performance and visual quality of life in participants with Irregular cornea disorders like keratoconus and other related conditions, who habitually wear corneal lenses in comparison with scleral lenses.