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Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia

NCT05448989 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-07-12

No results posted yet for this study

Summary

Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.

Conditions

  • Myopia

Interventions

DRUG

1% atropine 5+3

A method for myopia control using high-concentration atropine

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • Yan Xu, M.D. · Shanghai Eye Diseases Prevention Treatment Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2024-12-31

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 NCT05448989 on ClinicalTrials.gov