Development of Bioluminescent Myopia Prevention and Control Instrument and Evaluation of Its Effect on Myopia

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-12

Study Completion Date

2026-09-30

Brief Summary

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Based on the Tongren Myopia and Amblyopia Therapeutic Apparatus (a 650nm low-level red-light device) developed by the research team in the previous phase, the device was modified by replacing the light source with LED light. Subsequently, a population study was conducted to evaluate its efficacy and safety in myopia prevention and control.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LED red-light

Group Type EXPERIMENTAL

RED-light device using LED light source

Intervention Type DEVICE

The light source type of red light is LED light source.

control

Fake light, with a light source power that is one-tenth of that of real LED light

Group Type SHAM_COMPARATOR

Control

Intervention Type DEVICE

Fake light, with a light source power that is one-tenth of that of real LED light

Interventions

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RED-light device using LED light source

The light source type of red light is LED light source.

Intervention Type DEVICE

Control

Fake light, with a light source power that is one-tenth of that of real LED light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Willing to use myopia treatment devices based on LED light sources or fake light sources Aged 6-18 years old For both eyes, the myopic spherical equivalent refraction after cycloplegic computerized refraction: -0.50D to -6.00D, and astigmatism ≤ 2.50D Spherical equivalent anisometropia of both eyes ≤ 2.50D Corrected visual acuity (for both near and far) ≥ 1.0 Intraocular pressure (IOP) 10-21mmHg No active ocular inflammation, no history of ocular trauma, no history of ocular surgery, and no ocular or systemic organic diseases that affect visual changes Voluntarily participate in this project and sign the informed consent form The subject has not used other myopia control methods in the past six months Have records of refractive error and axial length measurements six months before enrollment

Exclusion Criteria

* Subjects with systemic diseases or immune diseases that affect compliance, such as tumors, heart diseases (including those with implanted electronic devices in the body, such as cardiac pacemakers), severe liver and kidney diseases, epilepsy, and autoimmune diseases Subjects with mental illnesses that affect the implementation of the intervention measures in this trial Subjects with refractive media opacity (corneal lesions, lens opacity, etc.) or ocular diseases: macular diseases, moderate to severe dry eye, corneal diseases, cataracts, vitreoretinal diseases, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve dysplasia, or other ocular diseases Subjects allergic to cycloplegics Other circumstances where the researcher deems it inappropriate for the subject to participate in the trial for safety reasons or in the interest of the patient

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No