Lens wettability and subjective comfort of Euclid orthokeratology lenses with and without an enhanced coating will be compared in 50 children. Axial elongation will be monitored in pediatric patients who qualify and consent.
The primary objective of this trial is to provide an assessment of the lens wettability and patient comfort with an enhanced surface treatment for the Emerald Lens design when used by practitioners with moderate experience with fitting Euclid orthokeratology lenses. The hypothesis to be tested is that the proportion of participants with a lens wettability score of \> 3 (on a 5 point scale) with the enhanced surface treatment will be greater than that of the current lens surface, using a 1 to 5 scale The primary outcome variable is lens wettability as measured on eye using a 1 to 5 scale This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Lens with the current coating
Lens with the enhanced coating
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, United States
Pinecone Vision Center
Sartell, Minnesota, United States
Somerset Eye Care
North Brunswick, New Jersey, United States
Southern College of Optometry
Memphis, Tennessee, United States
Lens wettability
Lens wettability as measured on eye using a 1 to 5 scale
Time frame: 12 months
Patient comfort ratings
Patient comfort as measured by patient reported outcome using a 1 to 5 scale
Time frame: 12 months
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Specialty Eyecare Group
Kirkland, Washington, United States