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

January 9, 2023 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.01% atropine
0.01% atropine eye drop
Drug: low concentration atropine (0.01%)
0.01% atropine eye drop
Experimental: 0.025% atropine
0.025% atropine eye drop
Drug: low concentration atropine (0.025%)
0.025% atropine eye drop
Experimental: 0.05% atropine
0.05% atropine eye drop
Drug: low concentration atropine (0.05%)
0.05% atropine eye drop
Other: cross-over
first year: placebo second year: 0.05% atropine eye drop
Drug: Placebo
Placebo eye drop
Drug: low concentration atropine (0.05%)
0.05% atropine eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of SE changes over -0.75D
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
AL change
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Peking University People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shandong University of Traditional Chinese Medicine

Investigators

  • Study Director: Haidong Zou, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kjb-atp-v1.1-20220825

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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