A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children

A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children

Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

Inclusion Criteria:

• At the time of signing the informed consent form, the subject's age must be ≥6 years and <10 years (6-9.99 years);
• Both eyes are not myopic (SE>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D< SE under cycloplegia ≤+0.75D); [spherical equivalent (SE)=Sph+Cyl/2]
• Astigmatism ≤1.00D in each eye;
• Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
• Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
• Be in good general health;
• Be able to actively cooperate with the intervention plan and ophthalmological examination;
• Normal binocular vision
• At least one parent with SER ≤-3.00 D

Exclusion Criteria:

• Incapable of expressing consent
• All categories of persons particularly protected by law
• Subject in another study which might have an influence on vision or interfere with study assessment.
• Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
• History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
• Those who are allergic cycloplegic drugs;
• Other reasons that the investigator considers inappropriate for inclusion in the study.