The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Shanghai Eye Disease Prevention and Treatment Center

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.

Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Study Overview

• Status: Recruiting
• Conditions: High Myopia
• Intervention / Treatment: Drug: Atropine

• Study Type: Interventional
• Enrollment (Anticipated): 357
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xun Xu, MD; Phone Number: +86-021-63240090; Email: drxuxun@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai General Hospital
    • Contact: Bilian Ke; Email: 18817821693@126.com
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Jibo Zhou; Email: chedanyang_sjtu@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai Eye Disease Prevention & Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is less than 80 seconds, far exotropia is less than 10 prism degrees, far esotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D;
• Myopia progressed more than 0.5D in the past year;
• Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
• Written informed consent of guardian and child.

Exclusion Criteria:

• Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis;
• Systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological diseases, congenital heart disease, arrhythmia;
• Atropine allergy;
• Very low birth weight infants with birth weight less than 1500g;
• Receiving other treatment to control the development of myopia, including anticholinergic drugs such as atropine, or participated in other functional frame lens, multifocal soft lens in the past one year;
• Other situations that not suitable for participating in the trial as judged by the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; 0.01% atropine	Drug: Atropine; different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children
EXPERIMENTAL: Group 2; 0.04% atropine	Drug: Atropine; different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children
EXPERIMENTAL: Group 3; 0.1% atropine	Drug: Atropine; different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	at least 3 years
changes of axial length	AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar	at least 3 years

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Director: Xun Xu, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2021
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; 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: SHDC12019111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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