NCT07412678

Brief Summary

This study, led by Jie ying from the Ophthalmology Department of Beijing Tongren Hospital Affiliated to Capital Medical University, is a researcher-initiated clinical trial (IIT) designed to evaluate the therapeutic efficacy of low-intensity red light therapy in adult patients with high myopia (spherical equivalent ≤ -6.00D) and extreme myopia (spherical equivalent ≤ -10.00D). With the escalating global prevalence of high and extreme myopia-especially in East Asia including China-and pathological myopia becoming a leading cause of irreversible blindness in Chinese adults, red light therapy has shown promising effects in slowing myopia progression in children but lacks clinical evidence for adult populations, which constitutes the core rationale for this research.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

February 9, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Axial length

    Baseline, 3-month, 6-month, 9-month, 12-month

  • Sphearical equivalent error

    Baseline, 3-month, 6-month, 9-month, 12-month

Study Arms (2)

Red light

EXPERIMENTAL
Device: Red light

control

PLACEBO COMPARATOR
Other: Single vision spectacle lenses

Interventions

Red lightDEVICE

Subjects receive low-intensity single-wavelength red light therapy using the Tongren Myopia and Amblyopia Therapeutic Apparatus , administered twice daily for 3 minutes per session with an interval of at least 4 hours, combined with single-vision frame glasses.

Red light
Single vision spectacle lensesOTHER

Myopia correction, optic way

control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 45 years old. Spherical equivalent refraction of -6.00D to -20.00D in one or both eyes measured by cycloplegic computer optometry.
  • Intraocular pressure (IOP) ranging from 10 to 21 mmHg. Clear crystalline lens (cataract excluded). No active ocular inflammation, history of ocular trauma or surgery, and no ocular or systemic organic diseases that affect visual acuity changes.
  • Voluntarily participate in the study and sign the informed consent form. Willing to use the Tongren Myopia and Amblyopia Therapeutic Apparatus (Patent No.: 202022533301.4, manufactured by Hunan Yifan Technology Co., Ltd.) or accept the above-mentioned control treatment.

You may not qualify if:

  • Patients with the following ocular diseases: choroidal neovascularization, macular hemorrhage, macular schisis, extensive chorioretinal atrophy, and refractive media opacity (such as corneal lesions, lens opacity, etc.).
  • Subjects with systemic or immune diseases that affect compliance, including tumors, heart diseases (with implanted electronic devices such as cardiac pacemakers), severe hepatic and renal diseases, epilepsy, autoimmune diseases, etc.
  • Subjects with mental disorders that interfere with the implementation of intervention measures in this trial.
  • Hypersensitivity to cycloplegic agents. Other circumstances deemed inappropriate for participation in the trial by the investigator for safety reasons or the patient's benefit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Kai Cao

CONTACT

01058265900anzhen602@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

March 11, 2027

Study Completion (Estimated)

March 11, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)