The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.
The primary objective of this trial is to provide an assessment of the "first fit" success of the Euclid orthokeratology "Phoenix" lens design versus its current "MAX" lens design when used by practitioners with moderate experience with fitting Euclid MAX orthokeratology lenses. The hypothesis to be tested is that the "first fit" success of the redesign Euclid MAX "Phoenix" lens design is greater than that of the current MAX lens design. The primary outcome variable is the percentage of participants successfully fit with the first lenses empirically ordered for the existing MAX lens design versus a modified MAX lens ("Phoenix") design. 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
30
The current lens design
The new lens design
Insight Vision Center Optometry
Costa Mesa, California, United States
Dau Family Eye Care
Saint Johns, Florida, United States
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, United States
Somerset Eye Care
North Brunswick, New Jersey, United States
First fit success rate
Percentage of children successfully fit in the first lens pair ordered (as determined by the PI)
Time frame: 1 month
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Treehouse Eyes
Tysons Corner, Virginia, United States