A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Shanghai Eye Disease Prevention and Treatment Center0 sites588 target enrollmentJanuary 15, 2023

Interventionslow concentration atropine (0.01%)low concentration atropine (0.025%)low concentration atropine (0.05%)Placebo

Drugslow concentration atropine (0.05%)Placebo low concentration atropine (0.01%)low concentration atropine (0.025%)

Overview

Phase: Not Applicable
Intervention: low concentration atropine (0.01%)
Conditions: Myopia, Progressive
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Enrollment: 588
Primary Endpoint: Proportion of SE changes over -0.75D
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 15, 2023

End Date

November 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The age of the screening stage is 3-15 years, both sexes;
•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;
•Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
•Informed consent from the guardian and the child.