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

NCT05357326 | Unknown Phase 4 DMC

• 1 other identifier: SHYB2021003
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia progression; atropine; orthokeratology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• lens power change over two years

  2 years

• choroidal thickness change over two years

  2 years

• choroidal blood flow density change over two years

  2 years

• anterior chamber depth change over two years

  2 years

• intraocular pressure change over two years

  2 years

Study Arms (3)

0.01% atropine

ACTIVE COMPARATOR

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

Drug: Atropine Sulfate 0.01% Eye Drop

0.04% atropine

EXPERIMENTAL

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

Drug: Atropine Sulfate 0.04% Eye Drop

orthokeratology

EXPERIMENTAL

wear orthokeratology lens every night for two years

Device: Orthokeratology

Interventions

Atropine Sulfate 0.01% Eye Drop DRUG

use one drop into subconjunctiva

0.01% atropine

Orthokeratology DEVICE

wear orthokeratology at night while sleeping

orthokeratology

Atropine Sulfate 0.04% Eye Drop DRUG

use one drop into subconjunctiva

0.04% atropine

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Jianfeng Zhu

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (1)

• Xu H, Chen M, Ye L, Shu Q, Peng Y, Liang X, Yu T, Ji Y, Li S, Shen Q, He J, Li L, Zhu J, Xu X. Orthokeratology, 0.04% Atropine, and 0.01% Atropine for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jul 24;143(9):731-8. doi: 10.1001/jamaophthalmol.2025.2321. Online ahead of print.

  PMID: 40705323 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Jianfeng Zhu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jianfeng Zhu

CONTACT

13501822932; jfzhu1974@Hotmail.com

Jiangnan He

CONTACT

18101853556; hejiangnan85@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: May 2, 2022
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 31, 2023
• Last Updated: May 2, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)