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

Primary Purpose

Myopia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Atropine Sulfate 0.01% Eye Drop
Orthokeratology
Atropine Sulfate 0.04% Eye Drop
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia progression, atropine, orthokeratology

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jianfeng ZhuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

0.01% atropine

0.04% atropine

orthokeratology

Arm Description

use atropine sulfate 0.01% eye drop every night before sleep for two years

use atropine sulfate 0.04% eye drop every night before sleep for two years

wear orthokeratology lens every night for two years

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2021
Last Updated
April 26, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT05357326
Brief Title
Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model
Official Title
Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia progression, atropine, orthokeratology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.01% atropine
Arm Type
Active Comparator
Arm Description
use atropine sulfate 0.01% eye drop every night before sleep for two years
Arm Title
0.04% atropine
Arm Type
Experimental
Arm Description
use atropine sulfate 0.04% eye drop every night before sleep for two years
Arm Title
orthokeratology
Arm Type
Experimental
Arm Description
wear orthokeratology lens every night for two years
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 0.01% Eye Drop
Intervention Description
use one drop into subconjunctiva
Intervention Type
Device
Intervention Name(s)
Orthokeratology
Intervention Description
wear orthokeratology at night while sleeping
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 0.04% Eye Drop
Intervention Description
use one drop into subconjunctiva
Primary Outcome Measure Information:
Title
spherical equivalent progression in over two years
Description
equals sphere +1/2 cylinder
Time Frame
2 years
Title
axial length change over two years
Description
measured by IOL-Master
Time Frame
2 years
Secondary Outcome Measure Information:
Title
lens power change over two years
Description
calculated by Bennett-Rabetts formula
Time Frame
2 years
Title
choroidal thickness change over two years
Description
measured by SS-OCT
Time Frame
2 years
Title
choroidal blood flow density change over two years
Description
measured by OCTA
Time Frame
2 years
Title
anterior chamber depth change over two years
Description
measured by IOL-Master
Time Frame
2 years
Title
intraocular pressure change over two years
Description
measured by a non-contact tonometer
Time Frame
2 years
Title
corneal topography change over two years
Description
measured by Pentacam
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Zhu
Phone
13501822932
Ext
18101853556
Email
jfzhu1974@Hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiangnan He
Phone
18101853556
Ext
18101853556
Email
hejiangnan85@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Zhu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Jianfeng Zhu
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Zhu
Phone
13501822932
Ext
13501822932
Email
jfzhu1974@Hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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