Atropine for Children and Adolescent Myopia Progression Study

NCT03949101 | Unknown Phase 4 DMC

• 1 other identifier: YFZX2019001
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are going to conduct a randomized controlled trial that myopic children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group) in order to explore a better way to control myopia progression and eliminate adverse effects at the same time, provide reliably evidence for clinical guideline of atropine use in children, and investigate the mechanism of atropine on eyes.

Conditions

Myopia

Keywords

myopia progression; atropine; prospective study

Outcome Measures

Primary Outcomes (2)

• spherical equivalent progression in a year

  equals sphere +1/2 cylinder

  2 years

• axial length change in a year

  measured by IOL-Master

  2 years

Secondary Outcomes (6)

• lens power change in a year

  2 years

• choroidal thickness change in a year

  2 years

• choroidal blood flow density change in a year

  2 years

• anterior chamber depth

  2 years

• intraocular pressure

  2 years

Study Arms (2)

combined use of 1% atropine and 0.01% atropine

EXPERIMENTAL

first week, use atropine sulfate 1% ophthalmic ointment every night before sleep; then use atropine sulfate 1% ophthalmic ointment once every week(Friday night before sleep is recommended) for half a year; then use atropine sulfate 0.01% eye drop every night before sleep for one year and a half.

Drug: Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop

0.01% atropine

ACTIVE COMPARATOR

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

Drug: atropine 0.01% eye drop

Interventions

Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop DRUG

use one drop into subconjunctiva

combined use of 1% atropine and 0.01% atropine

atropine 0.01% eye drop DRUG

use one drop into subconjunctiva

0.01% atropine

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged from 7-12 years old;
• children with spherical equivalent ranged from -0.5D to -6.0D;
• 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;
• children who are severly allergic with atropine;
• children who are using other eye drops for treatment;
• 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

Study Sites (1)

Jianfeng Zhu

Shanghai, Shanghai Municipality, 20040, China

Location

Related Publications (3)

• Zhao LQ, Ye LY, Chen J, Zhu XF, Xu HN, Yu T, Peng YJ, He JN, Zhu JF. Comparison of the influence of 1% and 0.01% atropine on the corneal topography in myopic children. BMC Ophthalmol. 2025 Nov 18;25(1):650. doi: 10.1186/s12886-025-04465-2.

  PMID: 41254600 DERIVED

• Xu H, Ye L, Peng Y, Yu T, Li S, Weng S, Huang Y, Chen Y, Fan Y, Zou H, He J, Zhu J, Xu X. Potential Choroidal Mechanisms Underlying Atropine's Antimyopic and Rebound Effects: A Mediation Analysis in a Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2023 Apr 3;64(4):13. doi: 10.1167/iovs.64.4.13.

  PMID: 37043339 DERIVED

• Ye L, Xu H, Shi Y, Yin Y, Yu T, Peng Y, Li S, He J, Zhu J, Xu X. Efficacy and Safety of Consecutive Use of 1% and 0.01% Atropine for Myopia Control in Chinese Children: The Atropine for Children and Adolescent Myopia Progression Study. Ophthalmol Ther. 2022 Dec;11(6):2197-2210. doi: 10.1007/s40123-022-00572-1. Epub 2022 Sep 29.

  PMID: 36175821 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group), each group includes 111 children,

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 14, 2019
• Study Start: May 8, 2019
• Primary Completion: May 8, 2021
• Study Completion: September 1, 2021
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

CN (1)