This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Test Soft Contact Lens
CONTROL
Centre for Ocular Research & Education
Waterloo, Ontario, Canada
Distance Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Near Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Time frame: Up to Post Lens Fitting Evaluation
Near Off-axis Refraction at ±30° Retinal Eccentricities.
Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
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Time frame: Up to Post Lens Fitting Evaluation