myopia
Conditions
Interventions
Placebo Control:The intervention is to instill eyedrop (placebo) once nightly for 1 year.
0.01% atropine:The intervention is to instill eyedrop ( 0.01% atropine) once nightly for 1 year.
0.04% atropine:The intervention is to instill eyedrop ( 0.04% atropine) once nightly for 1 year.
Sponsors
Eye Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Wearing a certain type of peripheral defocus design frame lens in the past 6 to 12 months, during which the growth rate of the binocular axis is >=0.20mm/year (calculation formula: the difference between the axial length of the two visits/the number of days between the two visits*365 days/year); 2. Refractive state (computerized refraction after cycloplegia): binocular equivalent spherical power between -1.00D (inclusive) ~ -6.00D (exclusive), anisometropic <=1.50D, astigmatism <=1.50D in either eye; 3. Age 6 (inclusive) ~ 10 (inclusive) years old 4. Both the subject and the guardian signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from strabismus, amblyopia or other eye diseases; 2. Intraocular pressure > 21mmHg in either eye, or intraocular pressure difference >5mmHg in both eyes; 3. Use atropine eye drops while wearing peripheral defocus design frame lenses; 4. Allergy or intolerance to atropine; 5. Inability to participate in regular follow-up visits; 6. The rest of the conditions determined by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year change in axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year change in cycloplegic spherical equivalent refraction;The proportion of subjects whose axial length change within 1 year is within the ideal control range (<0.20 mm/year).;The proportion of subjects whose myopic refractive progression within 1 year is within the ideal control range (<0.50 D/year).; | — |
Countries
China
Contacts
Public ContactMao, Xinjie
Eye Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed