Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents (LAMC)

Shanghai Eye Disease Prevention and Treatment Center

Status: Not yet enrolling

Conditions: Myopia, Progressive

Treatments: Drug: Placebo; Drug: low concentration atropine (0.05%); Drug: low concentration atropine (0.025%); Drug: low concentration atropine (0.01%)

Study type: Interventional

Funder types: Other

Identifiers

NCT05597163

kjb-atp-v1.1-20220825

Details and patient eligibility

About

To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

Enrollment: 588 estimated patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age of the screening stage is 3-15 years, both sexes;
2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
4. Informed consent from the guardian and the child.

Exclusion criteria

1. strabismus, amblyopia or other ocular abnormalities;
2. The presence of systemic disease abnormalities;
3. have taken myopia control treatment in the past month;
4. Allergic to low concentration atropine or sulfuric acid drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 4 patient groups

0.01% atropine

Experimental group

Description:

0.01% atropine eye drop

Treatment:

Drug: low concentration atropine (0.01%)

0.025% atropine

Experimental group

Description:

0.025% atropine eye drop

Treatment:

Drug: low concentration atropine (0.025%)

0.05% atropine

Experimental group

Description:

0.05% atropine eye drop

Treatment:

Drug: low concentration atropine (0.05%)

cross-over

Other group

Description:

first year: placebo second year: 0.05% atropine eye drop

Treatment:

Drug: Placebo

Drug: low concentration atropine (0.05%)