About this trial
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-25 years;
Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
The subject eye's best corrected visual acuity <= logMAR 0.1;
Disqualifiers
Current use of MC interventions or prior use of MC interventions within the past 6 months;
Disease or anatomical factors that affect the wearing of contact lenses;
History of myopia correction surgery;
Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
Trial design
Parallel
Treatments tested in this trial
MiSight® 1 day soft contact lenses
DeviceDual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Proclear® 1 day soft contact lenses
DeviceSingle-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Treatment groups
Trial outcomes
Primary outcomes
Change in cycloplegic spherical equivalent after 2 years
The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.
Secondary outcomes
Change in axial length after 2 years
The difference in the change of axial length between the intervention group and the control group.
Sponsors and contacts
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