Clinical trial NCT04699357: The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial
Official title: Shanghai Eye Disease Prevention and Treatment Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 357
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes of spherical equivalent
timeFrame: at least 3 years
measure: changes of axial length
timeFrame: at least 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xun Xu, MD
role: STUDY_DIRECTOR
References: