Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Myopia (Disorder) Anisometropia Eye Diseases Myopia Refractive Errors

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
Willingness to wear MiSight® 1 Day for ≥10 hours/day and ≥6 days/week.
Willingness of the participant and parents to comply with the study procedures and complete 12 months of follow-up.
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.

Treatment and study plan

MiSight® 1 day

Device

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

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

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Aug 21, 2026
Registry last updated: Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed