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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04699357
Other study ID # SHDC12019111
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 4, 2021
Est. completion date August 1, 2025

Study information

Verified date January 2021
Source Shanghai Eye Disease Prevention and Treatment Center
Contact Xun Xu, MD
Phone +86-021-63240090
Email drxuxun@sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.


Recruitment information / eligibility

Status Recruiting
Enrollment 357
Est. completion date August 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - The BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is less than 80 seconds, far exotropia is less than 10 prism degrees, far esotropia is less than 6-8 prism degrees, and astigmatism is equal to or less than - 2.50 D; - Myopia progressed more than 0.5D in the past year; - Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required; - Written informed consent of guardian and child. Exclusion Criteria: - Diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis; - Systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological diseases, congenital heart disease, arrhythmia; - Atropine allergy; - Very low birth weight infants with birth weight less than 1500g; - Receiving other treatment to control the development of myopia, including anticholinergic drugs such as atropine, or participated in other functional frame lens, multifocal soft lens in the past one year; - Other situations that not suitable for participating in the trial as judged by the researcher

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atropine
different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Locations

Country Name City State
China Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai
China Shanghai General Hospital Shanghai
China Shanghai Ninth People's Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes of spherical equivalent Spherical equivalent as measured by cycloplegia autorefraction at least 3 years
Primary changes of axial length AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar at least 3 years
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