Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

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

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.

Inclusion Criteria:

1. Age 7-18 years.
2. Cycloplegic SER ≤ -0.75 D in one eye and > -0.50 D in the fellow eye.
3. Cylinder ≤1.00 D in the myopic eye.
4. BCVA ≥20/25 (0.1 logMAR).
5. Willingness to wear MiSight® 1 Day for ≥10 hours/day and ≥6 days/week.
6. Willingness of the participant and parents to comply with the study procedures and complete 12 months of follow-up.
7. Written informed consent provided by the legal guardian.

Exclusion Criteria:

• 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.
• Amblyopia, strabismus, or other significant binocular visual dysfunction.
• Cataract, glaucoma, uveitis, retinal disease, or other significant ocular disease.
• Systemic connective-tissue or neurological disease affecting vision.
• Known allergy to atropine or contact lens materials.
• Inability to comply with scheduled visits or anticipated relocation during the study period.