Back to resultsThe Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial
Primary Purpose
High Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atropine
Sponsored by
About this trial
This is an interventional prevention trial for High Myopia
Eligibility Criteria
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
Sites / Locations
- Shanghai Eye Disease Prevention & Treatment CenterRecruiting
- Shanghai General HospitalRecruiting
- Shanghai Ninth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
0.01% atropine
0.04% atropine
0.1% atropine
Outcomes
Primary Outcome Measures
changes of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04699357
First Posted
January 6, 2021
Last Updated
January 10, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT04699357
Brief Title
The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial
Official Title
Shanghai Eye Disease Prevention and Treatment Center
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
357 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
0.01% atropine
Arm Title
Group 2
Arm Type
Experimental
Arm Description
0.04% atropine
Arm Title
Group 3
Arm Type
Experimental
Arm Description
0.1% atropine
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children
Primary Outcome Measure Information:
Title
changes of spherical equivalent
Description
Spherical equivalent as measured by cycloplegia autorefraction
Time Frame
at least 3 years
Title
changes of axial length
Description
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar
Time Frame
at least 3 years
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Xu, MD
Phone
+86-021-63240090
Email
drxuxun@sjtu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangui He, PhD
Email
xianhezi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Xu, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Eye Disease 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
Xun Xu, MD
Phone
86-13386259538
Email
drxuxun@tom.com
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilian Ke
Email
18817821693@126.com
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jibo Zhou
Email
chedanyang_sjtu@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial
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