Back to resultsLow Concentration Atropine in the Prevention of Myopia in Children.
Primary Purpose
Myopia, Progressive
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low concentration atropine (0.01%)
low concentration atropine (0.02%)
low concentration atropine (0.04%)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Myopia, Progressive
Eligibility Criteria
Inclusion Criteria: The age of the screening stage is 6-9 years, both sexes; One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0; At least one of parents suffers from myopia (SE of at least one eye <=-3.00D); Parents have signed informed consent and agree to participate in screening and follow-up. Exclusion Criteria: Parents disagree to sign the informed consent; Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery; Presence of other eye or systemic diseases; Allergies to low concentration atropine or sulfuric acid drugs; Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month; Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Sites / Locations
- Xiangui HeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.01% atropine
0.02% atropine
0.04% atropine
placebo
Arm Description
0.01% atropine eye drop
0.02% atropine eye drop
0.04% atropine eye drop
placebo eye drop
Outcomes
Primary Outcome Measures
Cumulative Incidence of Myopia
Effectiveness Evaluation
Secondary Outcome Measures
Changes in SE (after cycloplegia)
Effectiveness Evaluation
Changes in AL
Effectiveness Evaluation
Changes in visual acuity
Effectiveness Evaluation
Changes in Choroidal Thickness
Effectiveness Evaluation
Full Information
NCT ID
NCT05939882
First Posted
June 23, 2023
Last Updated
July 10, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT05939882
Brief Title
Low Concentration Atropine in the Prevention of Myopia in Children.
Official Title
A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
Detailed Description
The main questions this double-blind, randomized controlled clinical study aims to answer are:
To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.
Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
428 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.01% atropine
Arm Type
Experimental
Arm Description
0.01% atropine eye drop
Arm Title
0.02% atropine
Arm Type
Experimental
Arm Description
0.02% atropine eye drop
Arm Title
0.04% atropine
Arm Type
Experimental
Arm Description
0.04% atropine eye drop
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo eye drop
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.01%)
Intervention Description
low concentration atropine (0.01%)
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.02%)
Intervention Description
low concentration atropine (0.02%)
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.04%)
Intervention Description
low concentration atropine (0.04%)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drop
Primary Outcome Measure Information:
Title
Cumulative Incidence of Myopia
Description
Effectiveness Evaluation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in SE (after cycloplegia)
Description
Effectiveness Evaluation
Time Frame
1 year
Title
Changes in AL
Description
Effectiveness Evaluation
Time Frame
1 year
Title
Changes in visual acuity
Description
Effectiveness Evaluation
Time Frame
1 year
Title
Changes in Choroidal Thickness
Description
Effectiveness Evaluation
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Changes in Photophobia Incidence Rate
Description
Safety Evaluation
Time Frame
1 year
Title
Changes in Blurred Vision Incidence Rate
Description
Safety Evaluation
Time Frame
1 year
Title
change in amplitude of accommodation
Description
Safety Evaluation
Time Frame
1 year
Title
change in pupil size
Description
Safety Evaluation
Time Frame
1 year
Title
change in ocular surface health
Description
Safety Evaluation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age of the screening stage is 6-9 years, both sexes;
One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
Parents have signed informed consent and agree to participate in screening and follow-up.
Exclusion Criteria:
Parents disagree to sign the informed consent;
Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
Presence of other eye or systemic diseases;
Allergies to low concentration atropine or sulfuric acid drugs;
Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangui He
Phone
+8615000755422
Email
xianhezi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Wang
Phone
+8613011220922
Email
13011220922@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Xiangui
Organizational Affiliation
Shanghai Eye Disease Prevention and Treatment Center
Official's Role
Study Director
Facility Information:
Facility Name
Xiangui He
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangui He, MD
Phone
+8615000755422
Email
xianhezi@163.com
12. IPD Sharing Statement
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Low Concentration Atropine in the Prevention of Myopia in Children.
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