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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopic Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Novel plano spectacle lenses

Intervention Type DEVICE

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.

Control group

Objectively measuring outdoor time by smart bracelet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Novel plano spectacle lenses

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No