Myopia Intervention in Children and Adolescents and Estab... | NCT05357326

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

NCT05357326

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Status

Unknown status

Last Update Posted

May 2, 2022Actual

Enrollment

186Estimated

Phase

Phase 4

Conditions

Myopia

Interventions

Atropine Sulfate 0.01% Eye Drop
Orthokeratology
Atropine Sulfate 0.04% Eye Drop

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Apr 26, 2022

First Posted Date

May 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

May 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Shanghai Eye Disease Prevention and Treatment CenterOTHER

Collaborators

Name	Class
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atropine Sulfate 0.01% Eye Drop	Drug	use one drop into subconjunctiva	0.01% atropine

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Zhu	Contact	13501822932	18101853556	jfzhu1974@Hotmail.com
Jiangnan He	Contact	18101853556	18101853556	hejiangnan85@126.com

Overall Officials

Name	Affiliation	Role
Jianfeng Zhu	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jianfeng Zhu	Recruiting	Shanghai	Shanghai Municipality	200040	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40705323	Derived	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.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D001285	Atropine
D009883	Ophthalmic Solutions

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds