Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2025-11-01

Brief Summary

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To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

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Detailed Description

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Conditions

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Myopia, Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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0.01% atropine

0.01% atropine eye drop

Group Type EXPERIMENTAL

low concentration atropine (0.01%)

Intervention Type DRUG

0.01% atropine eye drop

0.025% atropine

0.025% atropine eye drop

Group Type EXPERIMENTAL

low concentration atropine (0.025%)

Intervention Type DRUG

0.025% atropine eye drop

0.05% atropine

0.05% atropine eye drop

Group Type EXPERIMENTAL

low concentration atropine (0.05%)

Intervention Type DRUG

0.05% atropine eye drop

cross-over

first year: placebo second year: 0.05% atropine eye drop

Group Type OTHER

low concentration atropine (0.05%)

Intervention Type DRUG

0.05% atropine eye drop

Placebo

Intervention Type DRUG

Placebo eye drop

Interventions

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low concentration atropine (0.01%)

0.01% atropine eye drop

Intervention Type DRUG

low concentration atropine (0.025%)

0.025% atropine eye drop

Intervention Type DRUG

low concentration atropine (0.05%)

0.05% atropine eye drop

Intervention Type DRUG

Placebo

Placebo eye drop

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The age of the screening stage is 3-15 years, both sexes;
2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
4. Informed consent from the guardian and the child.

Exclusion Criteria

1. strabismus, amblyopia or other ocular abnormalities;
2. The presence of systemic disease abnormalities;
3. have taken myopia control treatment in the past month;
4. Allergic to low concentration atropine or sulfuric acid drugs.

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No