Efficacy and Safety of 1% Atropine 5+3 Regimen in Children and Adolescents Controlling Myopia

Study Overview
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Brief Summary
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Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine 5+3 myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.

Detailed Description
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Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. Among them, low-concentration atropine has few side effects and is the primary recommendation, but many clinical practices and studies suggest that its effect in controlling myopia is limited. 1% atropine ophthalmic drug has obvious curative effect advantages in controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine 5+3 myopia control (eye instillation for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye), data from retrospective clinical studies have shown that it can significantly reduce side effects and improve compliance, but there is currently a lack of evidence from prospective clinical studies. Therefore, this study intends to use a randomized controlled trial, with 1% atropine used in both eyes once a week as the control group, to evaluate the effect of the 5+3 regimen in controlling myopia (spherical equivalent and axial length), safety (accommodation amplitude, amount of phoria, binocular vision function, etc.), and the compliance and side effects (photophobia, blurred vision, etc.).

Official Title
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Efficacy and Safety of 1% Atropine 5+3 Regimen in Children and Adolescents Controlling Myopia

Conditions
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Myopia

Intervention / Treatment
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* Drug: 1% atropine 5+3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 to 12 years old; Both eyes are in line with the diagnosis of myopic refractive error and 0.25D < myopia spherical lens <4.00D after mydriasis, astigmatism <2.00D, binocular anisometropia <3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8; Visual function: Timus≤100 seconds, exophoria <5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age); No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; The written informed consent of the guardian and the child himself. Exclusion Criteria: History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage; Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45; Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases; Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases; Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs; Received other treatments to control the development of myopia in the past, such as the use of anticholinergic drugs such as atropine within 3 months, or participated in other relevant researchers such as functional frame mirrors and multifocal flexible mirrors; Other circumstances judged by the investigator to be unsuitable to participate in the research.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% atropine 5+3<br>Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct used for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye Total treatment time 1 year | Drug: 1% atropine 5+3<br>* A method for myopia control using high-concentration atropine<br>|
| Placebo Comparator: 1% atropine weekly<br>Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct once a week in both eyes Total treatment time 1 year | Drug: 1% atropine 5+3<br>* A method for myopia control using high-concentration atropine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | Before atropine treatment | 
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | 1months after treatment | 
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | 3months after treatment | 
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | 6months after treatment | 
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | 9months after treatment | 
| spherical equivalent | spherical equivalent(SE)，Diopter(D), measured by subjective optometry | 12months after treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | Before atropine treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | 1months after treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | 3months after treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | 6months after treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | 9months after treatment | 
| axial length | axial length(AL), millimeter(mm), measured by IOL master | 12months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | Before atropine treatment | 
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | 1months after treatment | 
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | 3months after treatment | 
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | 6months after treatment | 
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | 9months after treatment | 
| accommodation amplitude | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) | 12months after treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | Before atropine treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | 1months after treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | 3months after treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | 6months after treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | 9months after treatment | 
| amount of phoria | measured by Von-Graefe method, degree(°) | 12months after treatment | 
| binocular vision function | measured by Titmus method, second | Before atropine treatment | 
| binocular vision function | measured by Titmus method, second | 1months after treatment | 
| binocular vision function | measured by Titmus method, second | 3months after treatment | 
| binocular vision function | measured by Titmus method, second | 6months after treatment | 
| binocular vision function | measured by Titmus method, second | 9months after treatment | 
| binocular vision function | measured by Titmus method, second | 12months after treatment | 
| photophobia | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire | 1months after treatment | 
| photophobia | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire | 3months after treatment | 
| photophobia | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire | 6months after treatment | 
| photophobia | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire | 9months after treatment | 
| photophobia | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire | 12months after treatment | 
| blurred vision | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire | 1months after treatment | 
| blurred vision | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire | 3months after treatment | 
| blurred vision | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire | 6months after treatment | 
| blurred vision | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire | 9months after treatment | 
| blurred vision | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire | 12months after treatment | 
| Other discomfort | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire | 1months after treatment | 
| Other discomfort | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire | 3months after treatment | 
| Other discomfort | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire | 6months after treatment | 
| Other discomfort | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire | 9months after treatment | 
| Other discomfort | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire | 12months after treatment |