Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorBuddhist Tzu Chi General Hospital
About this trial
This investigator-initiated prospective observational cohort study aims to establish the first longitudinal clinical database evaluating fellow-eye myopia development in children receiving monocular MiSight® 1 Day treatment for unilateral myopia.
All myopic eyes will receive MiSight® 1 Day as standard clinical care, while the fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution, will be initiated according to routine clinical practice and shared decision-making between the investigator and the child's parents The findings are expected to provide important evidence regarding fellow-eye refractive development, identify predictors of myopia conversion, optimize the timing of intervention, and support personalized myopia management in children with unilateral myopia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 7-18 years.
Cycloplegic SER ≤ -0.75 D in one eye and > -0.50 D in the fellow eye.
Cylinder ≤1.00 D in the myopic eye.
BCVA ≥20/25 (0.1 logMAR).
Disqualifiers
Previous orthokeratology treatment.
Previous atropine treatment exceeding one month.
Previous use of other myopia-control soft contact lenses.
Keratoconus, corneal degeneration, or other corneal disease.
Trial population
children aged 7-18 years with unilateral myopia who meet all eligibility criteria and whose parents/legal guardians provide written informed consent. The myopic eye must have a cycloplegic SER of ≤ -0.75 D, while the fellow eye must have a cycloplegic SER of \> -0.50 D. The myopic eye must have cylinder ≤1.00 D and BCVA of 20/25 or better. Participants must be willing to wear MiSight® 1 Day for at least 10 hours per day and 6 days per week and complete 12 months of follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MiSight® 1 Day
DeviceUnilateral myopia children receive MiSight® 1 Day treatment in the myopic eye， fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment.
Time frame
From enrollment to the end of treatment at 12 MONTHSLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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