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

NCT04699357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • High Myopia

Interventions

DRUG

Atropine

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

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • Xun Xu, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-04
Primary Completion
2024-08-21
Completion
2024-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699357 on ClinicalTrials.gov