Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1% atropine 5+3 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
A method for myopia control using high-concentration atropine
|
| Placebo Comparator: 1% atropine weekly 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
A method for myopia control using high-concentration atropine
|
Outcome Measures
Primary Outcome Measures
- spherical equivalent [Before atropine treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [1months after treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [3months after treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [6months after treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [9months after treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [12months after treatment]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- axial length [Before atropine treatment]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [1months after treatment]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [3months after treatment]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [6months after treatment]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [9months after treatment]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [12months after treatment]
axial length(AL), millimeter(mm), measured by IOL master
Secondary Outcome Measures
- accommodation amplitude [Before atropine treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- accommodation amplitude [1months after treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- accommodation amplitude [3months after treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- accommodation amplitude [6months after treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- accommodation amplitude [9months after treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- accommodation amplitude [12months after treatment]
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
- amount of phoria [Before atropine treatment]
measured by Von-Graefe method, degree(°)
- amount of phoria [1months after treatment]
measured by Von-Graefe method, degree(°)
- amount of phoria [3months after treatment]
measured by Von-Graefe method, degree(°)
- amount of phoria [6months after treatment]
measured by Von-Graefe method, degree(°)
- amount of phoria [9months after treatment]
measured by Von-Graefe method, degree(°)
- amount of phoria [12months after treatment]
measured by Von-Graefe method, degree(°)
- binocular vision function [Before atropine treatment]
measured by Titmus method, second
- binocular vision function [1months after treatment]
measured by Titmus method, second
- binocular vision function [3months after treatment]
measured by Titmus method, second
- binocular vision function [6months after treatment]
measured by Titmus method, second
- binocular vision function [9months after treatment]
measured by Titmus method, second
- binocular vision function [12months after treatment]
measured by Titmus method, second
- photophobia [1months after treatment]
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
- photophobia [3months after treatment]
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
- photophobia [6months after treatment]
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
- photophobia [9months after treatment]
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
- photophobia [12months after treatment]
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
- blurred vision [1months after treatment]
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
- blurred vision [3months after treatment]
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
- blurred vision [6months after treatment]
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
- blurred vision [9months after treatment]
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
- blurred vision [12months after treatment]
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
- Other discomfort [1months after treatment]
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
- Other discomfort [3months after treatment]
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
- Other discomfort [6months after treatment]
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
- Other discomfort [9months after treatment]
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
- Other discomfort [12months after treatment]
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Other Outcome Measures
- lens thickness [Before atropine treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [1months after treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [3months after treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [6months after treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [9months after treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [12months after treatment]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens power [Before atropine treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [1months after treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [3months after treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [6months after treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [9months after treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [12months after treatment]
lens power(LP), diopter(D), calculated by Bennett formula
- anterior chamber depth [Before atropine treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- anterior chamber depth [1months after treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- anterior chamber depth [3months after treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- anterior chamber depth [6months after treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- anterior chamber depth [9months after treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- anterior chamber depth [12months after treatment]
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
- corneal power [Before atropine treatment]
corneal power, diopter(D), measured by IOL master
- corneal power [1months after treatment]
corneal power, diopter(D), measured by IOL master
- corneal power [3months after treatment]
corneal power, diopter(D), measured by IOL master
- corneal power [6months after treatment]
corneal power, diopter(D), measured by IOL master
- corneal power [9months after treatment]
corneal power, diopter(D), measured by IOL master
- corneal power [12months after treatment]
corneal power, diopter(D), measured by IOL master
- central corneal thickness [Before atropine treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- central corneal thickness [1months after treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- central corneal thickness [3months after treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- central corneal thickness [6months after treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- central corneal thickness [9months after treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- central corneal thickness [12months after treatment]
central corneal thickness(CTC), micron(um), measured by IOL master
- retinal thickness [Before atropine treatment]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [1months after treatment]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [3months after treatment]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [6months after treatment]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [9months after treatment]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [12months after treatment]
retina thickness, microns(um), measured by SSOCT
- choroidal thickness [Before atropine treatment]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [1months after treatment]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [3months after treatment]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [6months after treatment]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [9months after treatment]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [12months after treatment]
choroidal thickness, microns(um), measured by SSOCT
- ciliary muscle thickness [Before atropine treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary muscle thickness [1months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary muscle thickness [3months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary muscle thickness [6months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary muscle thickness [9months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary muscle thickness [12months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [Before atropine treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [1months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [3months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [6months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [9months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [12months after treatment]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Eye Diseases Prevention & Treatment Center | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Shanghai Eye Disease Prevention and Treatment Center
Investigators
- Study Director: Yan Xu, M.D., Shanghai Eye Diseases Prevention Treatment Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 2021SQ001