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

NCT07208617 | Not Yet Recruiting

• 1 other identifier: BeijingTH LED
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Myopia; Red-light; LED light

Outcome Measures

Primary Outcomes (2)

• Axial length

  Key parameter monitoring myopia progression

  Baseline and 6-month follow-up

• Spherical equivalent error

  Baseline and 6-month follow-up

Study Arms (2)

LED red-light

EXPERIMENTAL

Device: RED-light device using LED light source

control

SHAM COMPARATOR

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

Device: Control

Interventions

RED-light device using LED light source DEVICE

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

LED red-light

Control DEVICE

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

control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China, 100730, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Kai Cao

CONTACT

01058265900; anzhen602@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: February 12, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)