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Not yet recruitingNCT07778264Updated Aug 21, 2026

Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia

An observational study in Myopia (Disorder) and Anisometropia, sponsored by Buddhist Tzu Chi General Hospital. Not yet recruiting. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Buddhist Tzu Chi General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
7 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia (Disorder)
  • Anisometropia
03

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
100 Months
Patient registry
Yes

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

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What researchers measure

Primary outcomes

  1. 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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07778264
Lead sponsor
Buddhist Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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