Low Concentration Atropine in the Prevention of Myopia in Children.

A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.

This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

Study Overview

• Status: Recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Drug: Placebo; Drug: low concentration atropine (0.01%); Drug: low concentration atropine (0.02%); Drug: low concentration atropine (0.04%)

Detailed Description

The main questions this double-blind, randomized controlled clinical study aims to answer are:

1. To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
2. To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.

Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangui He; Phone Number: +8615000755422; Email: xianhezi@163.com
• Study Contact Backup: Name: Jingjing Wang; Phone Number: +8613011220922; Email: 13011220922@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Xiangui He
      • Contact: Xiangui He, MD; Phone Number: +8615000755422; Email: xianhezi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age of the screening stage is 6-9 years, both sexes;
2. One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
3. At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
4. Parents have signed informed consent and agree to participate in screening and follow-up.

Exclusion Criteria:

1. Parents disagree to sign the informed consent;
2. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
3. Presence of other eye or systemic diseases;
4. Allergies to low concentration atropine or sulfuric acid drugs;
5. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
6. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.01% atropine; 0.01% atropine eye drop	Drug: low concentration atropine (0.01%); low concentration atropine (0.01%)
Experimental: 0.02% atropine; 0.02% atropine eye drop	Drug: low concentration atropine (0.02%); low concentration atropine (0.02%)
Experimental: 0.04% atropine; 0.04% atropine eye drop	Drug: low concentration atropine (0.04%); low concentration atropine (0.04%)
Placebo Comparator: placebo; placebo eye drop	Drug: Placebo; Placebo eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incidence of Myopia	Effectiveness Evaluation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in SE (after cycloplegia)	Effectiveness Evaluation	1 year
Changes in AL	Effectiveness Evaluation	1 year
Changes in visual acuity	Effectiveness Evaluation	1 year
Changes in Choroidal Thickness	Effectiveness Evaluation	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Photophobia Incidence Rate	Safety Evaluation	1 year
Changes in Blurred Vision Incidence Rate	Safety Evaluation	1 year
change in amplitude of accommodation	Safety Evaluation	1 year
change in pupil size	Safety Evaluation	1 year
change in ocular surface health	Safety Evaluation	1 year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Director: He Xiangui, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: jafakfakfa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No