The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Not Applicable

Recruiting

• Conditions: High Myopia
• Interventions: Drug: Atropine

• Registration Number: NCT04699357
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-07-04
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-26
• Primary Completion: 2024-09-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 357

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Atropine	0.04% atropine
Group 1	Atropine	0.01% atropine
Group 3	Atropine	0.1% atropine

Primary Outcome Measures

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

Trial Locations

Locations (3)

Shanghai General Hospital; 🇨🇳 Shanghai, China

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China