Low Concentration Atropine in the Prevention of Myopia in Children.

Myopia, Progressive Clinical Trial

Official title:

A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939882
• Other study ID #: jafakfakfa
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Xiangui He
• Phone: +8615000755422
• Email: xianhezi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

Description:

The main questions this double-blind, randomized controlled clinical study aims to answer are:

1. To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.

2. To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.

Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

1. The age of the screening stage is 6-9 years, both sexes;

2. One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was =-1.50D, and the best corrected far vision was at least 1.0;

3. At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);

4. Parents have signed informed consent and agree to participate in screening and follow-up.

Exclusion Criteria:

1. Parents disagree to sign the informed consent;

2. Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;

3. Presence of other eye or systemic diseases;

4. Allergies to low concentration atropine or sulfuric acid drugs;

5. Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;

6. Presence of other situations that the researchers think is not appropriate for patients to be included in the project.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Drug:
• low concentration atropine (0.01%)
low concentration atropine (0.01%)
• low concentration atropine (0.02%)
low concentration atropine (0.02%)
• low concentration atropine (0.04%)
low concentration atropine (0.04%)
• Placebo
Placebo eye drop

Locations

Country	Name	City	State
China	Xiangui He	Shanghai	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
Other	Changes in Photophobia Incidence Rate	Safety Evaluation	1 year
Other	Changes in Blurred Vision Incidence Rate	Safety Evaluation	1 year
Other	change in amplitude of accommodation	Safety Evaluation	1 year
Other	change in pupil size	Safety Evaluation	1 year
Other	change in ocular surface health	Safety Evaluation	1 year
Primary	Cumulative Incidence of Myopia	Effectiveness Evaluation	1 year
Secondary	Changes in SE (after cycloplegia)	Effectiveness Evaluation	1 year
Secondary	Changes in AL	Effectiveness Evaluation	1 year
Secondary	Changes in visual acuity	Effectiveness Evaluation	1 year
Secondary	Changes in Choroidal Thickness	Effectiveness Evaluation	1 year