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

High Myopia Clinical Trial

Official title:

Shanghai Eye Disease Prevention and Treatment Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699357
• Other study ID #: SHDC12019111
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• High Myopia
• Myopia

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