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

Primary Purpose

Myopia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
1% atropine 5+3
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Eye Diseases Prevention & Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1% atropine 5+3

1% atropine weekly

Arm Description

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

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

Outcomes

Primary Outcome Measures

spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master

Secondary Outcome Measures

accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
amount of phoria
measured by Von-Graefe method, degree(°)
amount of phoria
measured by Von-Graefe method, degree(°)
amount of phoria
measured by Von-Graefe method, degree(°)
amount of phoria
measured by Von-Graefe method, degree(°)
amount of phoria
measured by Von-Graefe method, degree(°)
amount of phoria
measured by Von-Graefe method, degree(°)
binocular vision function
measured by Titmus method, second
binocular vision function
measured by Titmus method, second
binocular vision function
measured by Titmus method, second
binocular vision function
measured by Titmus method, second
binocular vision function
measured by Titmus method, second
binocular vision function
measured by Titmus method, second
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire

Full Information

First Posted
June 28, 2022
Last Updated
July 11, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT05448989
Brief Title
Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Official Title
Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1% atropine 5+3
Arm Type
Experimental
Arm Description
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
Arm Title
1% atropine weekly
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
1% atropine 5+3
Intervention Description
A method for myopia control using high-concentration atropine
Primary Outcome Measure Information:
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
Before atropine treatment
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
1months after treatment
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
3months after treatment
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
6months after treatment
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
9months after treatment
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
12months after treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
Before atropine treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
1months after treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
3months after treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
6months after treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
9months after treatment
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
12months after treatment
Secondary Outcome Measure Information:
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
Before atropine treatment
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
1months after treatment
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
3months after treatment
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
6months after treatment
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
9months after treatment
Title
accommodation amplitude
Description
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Time Frame
12months after treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
Before atropine treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
1months after treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
3months after treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
6months after treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
9months after treatment
Title
amount of phoria
Description
measured by Von-Graefe method, degree(°)
Time Frame
12months after treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
Before atropine treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
1months after treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
3months after treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
6months after treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
9months after treatment
Title
binocular vision function
Description
measured by Titmus method, second
Time Frame
12months after treatment
Title
photophobia
Description
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
1months after treatment
Title
photophobia
Description
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
3months after treatment
Title
photophobia
Description
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
6months after treatment
Title
photophobia
Description
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
9months after treatment
Title
photophobia
Description
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
12months after treatment
Title
blurred vision
Description
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
1months after treatment
Title
blurred vision
Description
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
3months after treatment
Title
blurred vision
Description
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
6months after treatment
Title
blurred vision
Description
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
9months after treatment
Title
blurred vision
Description
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Time Frame
12months after treatment
Title
Other discomfort
Description
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Time Frame
1months after treatment
Title
Other discomfort
Description
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Time Frame
3months after treatment
Title
Other discomfort
Description
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Time Frame
6months after treatment
Title
Other discomfort
Description
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Time Frame
9months after treatment
Title
Other discomfort
Description
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Time Frame
12months after treatment
Other Pre-specified Outcome Measures:
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
Before atropine treatment
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
1months after treatment
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
3months after treatment
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
6months after treatment
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
9months after treatment
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
12months after treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
Before atropine treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
1months after treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
3months after treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
6months after treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
9months after treatment
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
12months after treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
Before atropine treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
1months after treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
3months after treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
6months after treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
9months after treatment
Title
anterior chamber depth
Description
anterior chamber depth(ACD), millimeter(mm), measured by IOL master
Time Frame
12months after treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
Before atropine treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
1months after treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
3months after treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
6months after treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
9months after treatment
Title
corneal power
Description
corneal power, diopter(D), measured by IOL master
Time Frame
12months after treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
Before atropine treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
1months after treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
3months after treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
6months after treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
9months after treatment
Title
central corneal thickness
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
12months after treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
Before atropine treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
1months after treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
3months after treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
6months after treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
9months after treatment
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
12months after treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
Before atropine treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
1months after treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
3months after treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
6months after treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
9months after treatment
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
12months after treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
Before atropine treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
1months after treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
3months after treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
6months after treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
9months after treatment
Title
ciliary muscle thickness
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
12months after treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
Before atropine treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
1months after treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
3months after treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
6months after treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
9months after treatment
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
12months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Xu, M.D.
Phone
+86 18621080996
Email
drxuyan_2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Xu, M.D.
Organizational Affiliation
Shanghai Eye Diseases Prevention Treatment Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Eye Diseases Prevention & Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Zou, M.D.
Phone
+86 13311986528
Email
zouhaidong@sjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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