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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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% atropine 5+3 | Experimental | 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 |
|
| 1% atropine weekly | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% atropine 5+3 | Drug | A method for myopia control using high-concentration atropine |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master | Before atropine treatment |
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu, M.D. | Contact | +86 18621080996 | drxuyan_2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Xu, M.D. | Shanghai Eye Diseases Prevention Treatment Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Diseases Prevention & Treatment Center | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2022 | Jul 2, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 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 |
| 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 |
| 1months after treatment |
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master | 3months after treatment |
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master | 6months after treatment |
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master | 9months after treatment |
| lens thickness | lens thickness(LT), millimeter(mm), measured by IOL master | 12months after treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | Before atropine treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | 1months after treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | 3months after treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | 6months after treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | 9months after treatment |
| lens power | lens power(LP), diopter(D), calculated by Bennett formula | 12months after treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | Before atropine treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | 1months after treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | 3months after treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | 6months after treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | 9months after treatment |
| anterior chamber depth | anterior chamber depth(ACD), millimeter(mm), measured by IOL master | 12months after treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | Before atropine treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | 1months after treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | 3months after treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | 6months after treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | 9months after treatment |
| corneal power | corneal power, diopter(D), measured by IOL master | 12months after treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | Before atropine treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | 1months after treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | 3months after treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | 6months after treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | 9months after treatment |
| central corneal thickness | central corneal thickness(CTC), micron(um), measured by IOL master | 12months after treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | Before atropine treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | 1months after treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | 3months after treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | 6months after treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | 9months after treatment |
| retinal thickness | retina thickness, microns(um), measured by SSOCT | 12months after treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | Before atropine treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | 1months after treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | 3months after treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | 6months after treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | 9months after treatment |
| choroidal thickness | choroidal thickness, microns(um), measured by SSOCT | 12months after treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | Before atropine treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 1months after treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 3months after treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 6months after treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 9months after treatment |
| ciliary muscle thickness | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 12months after treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | Before atropine treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 1months after treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 3months after treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 6months after treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 9months after treatment |
| the distance between ciliary muscle apex and scleral spur | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software | 12months after treatment |