Myopia
Conditions
Interventions
The subjects will be assigned randomly to the trial device or control device at a 1:1 ratio and wear the assigned device every day for 12 months. This will be followed by 12-month follow-up period wit
Sponsors
Tsubota Kazuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female Japanese schoolchildren who are 6 to 12 years old at the time of informed consent - Anisometropia is within 1.50 D - Astigmatism, cycloplegic objective refraction (C), is within +/- 1.50 D for each eye
Exclusion criteria
Exclusion criteria: - A history of refractive and/or other form of ophthalmic surgery - Impaired binocular visual function - Amblyopia or manifest strabismus - Individuals who are likely to require contact lenses (e.g., monofocal, bifocal, orthokeratology) or multifocal eyeglasses during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in cycloplegic objective refraction: SE at Month 12 of investigational device use | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in axial length at Months 1, 3, 6, 9, and 12 of device use, and others | — |
Contacts
Public ContactShinichiro Kondo
Tsubota Laboratory, Inc.
Outcome results
None listed