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NOT YET RECRUITING
NCT07778264

Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

Sponsor: Buddhist Tzu Chi General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Natural History and Post-Conversion Clinical Outcomes of the Fellow Eye in Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia: A Prospective Cohort Study

Key Details

Gender

All

Age Range

7 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-09-15

Completion Date

2029-12-31

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DEVICE

MiSight® 1 Day

Unilateral 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