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

Shanghai Eye Disease Prevention and Treatment Center

Status: Active, not recruiting

Conditions: Myopic Children

Treatments: Device: Novel plano spectacle lenses

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06860737

WS10405

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 388 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

388 participants in 2 patient groups

Intervention group

Experimental group

Description:

Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.

Treatment:

Device: Novel plano spectacle lenses

Control group

No Intervention group

Description:

Objectively measuring outdoor time by smart bracelet.