Accommodative insufficiency, myopia
Conditions
Interventions
Test group:0.01% atropine sulfate eye drops
Control group:Vehicle for atropine sulfate eye drops
Sponsors
Tianjin Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent has been obtained from the children and their legal guardians. 2. Age range of 6-12 years old (inclusive). 3. After cycloplegia, the computerized refraction test measured the spherical equivalent refraction of both eyes as: -5.00D <= Spherical Equivalent <= -0.75D. 4. After cycloplegia, the computerized refraction test measured the cylinder power of both eyes as: Cylinder Power <= 2.00D. 5. Spherical equivalent anisometropia <= 1.50D. 6. The amplitude of accommodation is below the minimum value for the corresponding age by more than 2D (the minimum value for the corresponding age: 15 - 0.25 × age), and is greater than or equal to 5D. 7. Monocular (right eye) flipper test at -2.00D shows difficulty in passing, and monocular accommodative facility is less than 6 cycles per minute (cpm).
Exclusion criteria
Exclusion criteria: 1. Subjects who may may suffer from ocular diseases affecting vision or refractive error (e.g., cataracts and other lens injury diseases, glaucoma, macular degeneration, corneal disease, uveitis, retinal detachment, severe vitreous opacity, or any pathological change in the eyeball or acute ophthalmic inflammatory disease). 2. Systemic disease: Immune system disease, central nervous system disease, Down syndrome, asthma, a history of severe cardiopulmonary or severe liver or kidney function disorders. No history of head trauma or concussion. 3. Manifest strabismus at distance or near. 4. Use of myopia control treatment within the past three months, including medications: such as atropine, or pirenzepine, etc.; or devices: orthokeratology lenses, multifocal soft lenses, multifocal rigid lenses, functional spectacle lenses, etc. 5. Use of any medication that may interfere with the efficacy evaluation within three months prior to screening, such as anticholinergic drugs: atropine, pirenzepine, etc.; parasympathomimetic drugs: pilocarpine, etc. 6. Subjects who are allergic to any of the drugs used in this study, such as atropine, cyclopentolate, etc. 7. Participation in any other drug clinical trial within three months prior to screening. 8. Other conditions that the investigator deems unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accommodative Amplitude;Accommodative Facility; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spherical Equivalent Refraction;Axial Length; | — |
Countries
China
Contacts
Public ContactLi Lihua
Tianjin Eye Hospital
Outcome results
None listed