The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
University of Waterloo School of Optometry
Waterloo, Ontario, Canada
University of Minho Clinical & Experiment Optometry Research Lab
Braga, Portugal
National University of Singapore Faculty of Medicine
Singapore, Singapore
Aston University Ophthalmic Research Group
Birmingham, United Kingdom
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Time frame: 12 months
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Time frame: 24 months
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Time frame: 36 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Time frame: 12 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Time frame: 24 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Time frame: 36 months
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: Baseline
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Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 12 months
Number of Participants With Biomicroscopic Findings
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 24 months
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time frame: 36 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 12 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 24 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Time frame: 36 months