Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model

Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning

Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine Sulfate 0.01% Eye Drop; Drug: Atropine Sulfate 0.04% Eye Drop; Device: Orthokeratology

Detailed Description

Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianfeng Zhu; Phone Number: 18101853556 13501822932; Email: jfzhu1974@Hotmail.com
• Study Contact Backup: Name: Jiangnan He; Phone Number: 18101853556 18101853556; Email: hejiangnan85@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Jianfeng Zhu
      • Contact: Jianfeng Zhu; Phone Number: 13501822932 13501822932; Email: jfzhu1974@Hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children aged from 8-15 years old;
• children with spherical degree ranged from -1.0D to -4.0D, cylindrical degree less than -1.50D, astigmatism with the rule less than -1.25D, astigmatism with other axial distribution less than -0.50, anisometropia less than -1.50D;
• children with BCVA less than 0.1 LogMAR for both eyes;
• children without other eye diseases except for ametropia

Exclusion Criteria:

• children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
• children with cycloplegia contradictions;
• children who have used atropine or orthokeratology;
• children who are severly allergic with atropine;
• children who are using other eye drops for treatment;
• children who have contraindications to orthokeratology or cannot cooperate with it;
• children with severe heart, lung, liver and kidney diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.01% atropine; use atropine sulfate 0.01% eye drop every night before sleep for two years	Drug: Atropine Sulfate 0.01% Eye Drop; use one drop into subconjunctiva
Experimental: 0.04% atropine; use atropine sulfate 0.04% eye drop every night before sleep for two years	Drug: Atropine Sulfate 0.04% Eye Drop; use one drop into subconjunctiva
Experimental: orthokeratology; wear orthokeratology lens every night for two years	Device: Orthokeratology; wear orthokeratology at night while sleeping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spherical equivalent progression in over two years	equals sphere +1/2 cylinder	2 years
axial length change over two years	measured by IOL-Master	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lens power change over two years	calculated by Bennett-Rabetts formula	2 years
choroidal thickness change over two years	measured by SS-OCT	2 years
choroidal blood flow density change over two years	measured by OCTA	2 years
anterior chamber depth change over two years	measured by IOL-Master	2 years
intraocular pressure change over two years	measured by a non-contact tonometer	2 years
corneal topography change over two years	measured by Pentacam	2 years

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Jianfeng Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: atropine; myopia progression; orthokeratology
• 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; Pharmaceutical Solutions; Mydriatics; Ophthalmic Solutions; Atropine
• Other Study ID Numbers: SHYB2021003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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