myopia
Conditions
Interventions
experimental group:0.02% Adenosine Triphosphate+conventional spectacle lenses
control group:0.01% Adenosine Triphosphate+conventional spectacle lenses
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. written informed consent signed by the child and legal guardian has been obtained; 2. Children aged 4 to 10 years old (including the threshold); 3. Equivalent spherical lens power in either eye as measured by computerised optometry after ciliary muscle paralysis: -3.00D= 0.8 in both eyes; 8. Intraocular pressure <=21mmHg in both eyes;
Exclusion criteria
Exclusion criteria: 1.Subjects who may have ocular diseases that affect visual acuity or refractive errors (e.g., lens disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.). 2.Subjects with a history of systemic diseases, including immune system disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, or severe hepatorenal impairment. 3.Subjects with manifest strabismus in one or both eyes, or any other pathological ocular changes, or acute inflammatory ocular diseases. 4.Subjects who have used myopia control interventions within 3 months, including pharmaceutical treatments (e.g., atropine, pirenzepine, etc.) and device-based therapies (e.g., orthokeratology lenses, multifocal soft contact lenses, multifocal rigid contact lenses, functional spectacle lenses, etc.). 5.Subjects who have used systemic or topical medications that may interfere with efficacy evaluation within 3 months prior to screening, including anticholinergics (e.g., atropine, pirenzepine, etc.) and cholinomimetics (e.g., pilocarpine, etc.). 6.Subjects with a known allergy to the drugs used in this study, including atropine, cyclopentolate, etc. 7.Subjects who have participated in other clinical drug trials within 3 months prior to screening. 8.Other circumstances deemed inappropriate by the investigators. 9.Subjects with chronic mental disorders or psychiatric abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equivalent spherical power after cycloplegic refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Intraocular pressure;Adverse events and serious adverse events;Adjustment Range/Adjustment Sensitivity;Eye tolerance;Lens;External eye and conjunctiva;Fundus examination;Choroidal Thickness and Choroidal Blood Flow;axial length;cornea; | — |
Countries
China
Contacts
Public ContactJie Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed