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Clinical Trials/NCT05597163
NCT05597163
Not yet recruiting
Not Applicable

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

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

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

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.

Exclusion Criteria

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

Arms & Interventions

0.01% atropine

0.01% atropine eye drop

Intervention: low concentration atropine (0.01%)

0.025% atropine

0.025% atropine eye drop

Intervention: low concentration atropine (0.025%)

0.05% atropine

0.05% atropine eye drop

Intervention: low concentration atropine (0.05%)

cross-over

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

Intervention: low concentration atropine (0.05%)

cross-over

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

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of SE changes over -0.75D

Time Frame: 2 years

Secondary Outcomes

  • AL change(2 years)

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