Clinical trial NCT05939882: Low Concentration Atropine in the Prevention of Myopia in Children.
Official title: A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 428
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Incidence of Myopia
timeFrame: 1 year
Secondary outcomes:
measure: Changes in SE (after cycloplegia)
timeFrame: 1 year
measure: Changes in AL
timeFrame: 1 year
measure: Changes in visual acuity
timeFrame: 1 year
measure: Changes in Choroidal Thickness
timeFrame: 1 year
Other outcomes:
measure: Changes in Photophobia Incidence Rate
timeFrame: 1 year
measure: Changes in Blurred Vision Incidence Rate
timeFrame: 1 year
measure: change in amplitude of accommodation
timeFrame: 1 year
measure: change in pupil size
timeFrame: 1 year
measure: change in ocular surface health
timeFrame: 1 year
Locations:
city: Shanghai
country: China
facility: Xiangui He
state: Shanghai
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: He Xiangui
role: STUDY_DIRECTOR
References: