Clinical Trial of safety and efficacy of KATT orthokeratology lenses
Research type
Research Study
Full title
Clinical Trial to evaluate safety and efficacy of KATT orthokeratology contact lenses
IRAS ID
302885
Contact name
James Wolffsohn
Contact email
Sponsor organisation
KATT Design Inc.
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Myopia (shortsightedness) prevalence is increasing worldwide and is considered as a major public health concern. Orthokeratology is a clinical technique that uses specially designed and fitted rigid contact lenses to reshape the cornea (the 'window' to the eye) temporarily for modifying or correcting the patient’s refractive error (myopia) to give perfect distance vision. While the main clinical application of orthokeratology is the reduction of myopia through reshaping the cornea, it has also been shown to be effective in slowing excessive eye growth and myopia progression.
Although studies have shown similar effectiveness across current designs, recent laboratory studies have suggested that moving the optical changes closer to the centre of the lens (as with the new KATT lens design) will increase the effectiveness.
This study will examine the effectiveness of the two KATT ortho-k contact lens models (BE Free and Moonlens) in children and adults to correct myopia, reduce axial eye length and myopia progression. The orthokeratology lenses are yet to be CE marked.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0233
Date of REC Opinion
27 Oct 2021
REC opinion
Unfavourable Opinion