The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Study Overview
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Brief Summary
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Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Official Title
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Shanghai Eye Disease Prevention and Treatment Center

Conditions
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High Myopia

Intervention / Treatment
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* Drug: Atropine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is less than 80 seconds, far exotropia is less than 10 prism degrees, far esotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D; Myopia progressed more than 0.5D in the past year; Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required; Written informed consent of guardian and child. Exclusion Criteria: Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis; Systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological diseases, congenital heart disease, arrhythmia; Atropine allergy; Very low birth weight infants with birth weight less than 1500g; Receiving other treatment to control the development of myopia, including anticholinergic drugs such as atropine, or participated in other functional frame lens, multifocal soft lens in the past one year; Other situations that not suitable for participating in the trial as judged by the researcher

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>0.01% atropine | Drug: Atropine<br>* different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children<br>|
| Experimental: Group 2<br>0.04% atropine | Drug: Atropine<br>* different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children<br>|
| Experimental: Group 3<br>0.1% atropine | Drug: Atropine<br>* different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of spherical equivalent | Spherical equivalent as measured by cycloplegia autorefraction | at least 3 years | 
| changes of axial length | AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar | at least 3 years |