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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699357
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
High Myopia Drug: Atropine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Shanghai Eye Disease Prevention and Treatment Center
Actual Study Start Date : July 4, 2021
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. changes of spherical equivalent [ Time Frame: at least 3 years ]
    Spherical equivalent as measured by cycloplegia autorefraction

  2. changes of axial length [ Time Frame: at least 3 years ]
    AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699357


Contacts
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Contact: Xun Xu, MD +86-021-63240090 drxuxun@sjtu.edu.cn
Contact: Xiangui He, PhD xianhezi@163.com

Locations
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China, Shanghai
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xun Xu, MD    86-13386259538    drxuxun@tom.com   
China
Shanghai General Hospital Recruiting
Shanghai, China
Contact: Bilian Ke       18817821693@126.com   
Shanghai Ninth People's Hospital Recruiting
Shanghai, China
Contact: Jibo Zhou       chedanyang_sjtu@163.com   
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Investigators
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Study Director: Xun Xu, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT04699357    
Other Study ID Numbers: SHDC12019111
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action