Anisometropia, Myopia (Disorder)
Conditions
Brief 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.
Interventions
DEVICEMiSight® 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
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment. | From enrollment to the end of treatment at 12 MONTHS |
Outcome results
None listed