Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

NCT07778264 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB 115-
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia (Disorder); Anisometropia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children aged 7-18 years with unilateral myopia who meet all eligibility criteria and whose parents/legal guardians provide written informed consent. The myopic eye must have a cycloplegic SER of ≤ -0.75 D, while the fellow eye must have a cycloplegic SER of \> -0.50 D. The myopic eye must have cylinder ≤1.00 D and BCVA of 20/25 or better. Participants must be willing to wear MiSight® 1 Day for at least 10 hours per day and 6 days per week and complete 12 months of follow-up.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Myopia; Anisometropia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-08