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

Not Applicable

Not yet recruiting

• Conditions: Myopia, Progressive
• Interventions: Drug: low concentration atropine (0.01%); Drug: low concentration atropine (0.025%); Drug: low concentration atropine (0.05%); Drug: Placebo

• Registration Number: NCT05597163
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-27
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Study Start: 2023-01-15
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 588

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.01% atropine	low concentration atropine (0.01%)	0.01% atropine eye drop
0.025% atropine	low concentration atropine (0.025%)	0.025% atropine eye drop
0.05% atropine	low concentration atropine (0.05%)	0.05% atropine eye drop
cross-over	low concentration atropine (0.05%)	first year: placebo second year: 0.05% atropine eye drop
cross-over	Placebo	first year: placebo second year: 0.05% atropine eye drop

Primary Outcome Measures

Name	Time	Method
Proportion of SE changes over -0.75D	2 years

Secondary Outcome Measures

Name	Time	Method
AL change	2 years