Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

N/ANot Yet RecruitingNCT07778264

Buddhist Tzu Chi General Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Myopia (Disorder)Anisometropia

Interventions

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 MONTHS