The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-04

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

0.01% atropine

Group Type ACTIVE_COMPARATOR

Atropine

Intervention Type DRUG

different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Group 2

0.04% atropine

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Group 3

0.1% atropine

Group Type EXPERIMENTAL

Atropine

Intervention Type DRUG

different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Interventions

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Atropine

different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No