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

N/AActive Not RecruitingNCT06860737

Shanghai Eye Disease Prevention and Treatment Center388 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

388

Conditions

Myopic Children

Interventions

Novel plano spectacle lensesDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 9 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiangui He

Shanghai, China