Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model
NCT ID: NCT05357326
Last Updated: 2022-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
186 participants
INTERVENTIONAL
2021-07-01
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.01% atropine
use atropine sulfate 0.01% eye drop every night before sleep for two years
Atropine Sulfate 0.01% Eye Drop
use one drop into subconjunctiva
0.04% atropine
use atropine sulfate 0.04% eye drop every night before sleep for two years
Atropine Sulfate 0.04% Eye Drop
use one drop into subconjunctiva
orthokeratology
wear orthokeratology lens every night for two years
Orthokeratology
wear orthokeratology at night while sleeping
Interventions
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Atropine Sulfate 0.01% Eye Drop
use one drop into subconjunctiva
Orthokeratology
wear orthokeratology at night while sleeping
Atropine Sulfate 0.04% Eye Drop
use one drop into subconjunctiva
Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
15 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai Eye Disease Prevention and Treatment Center
OTHER
Responsible Party
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Principal Investigators
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Jianfeng Zhu
Role: STUDY_CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Jianfeng Zhu
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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SHYB2021003
Identifier Type: -
Identifier Source: org_study_id
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