Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia

February 9, 2026 updated by: Ying Jie, Beijing Tongren Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Beijing Tongren Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
Other: Single vision spectacle lenses
Myopia correction, optic way
Experimental: Red light
Device: Red light
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axial length
Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month
Baseline, 3-month, 6-month, 9-month, 12-month
Sphearical equivalent error
Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month
Baseline, 3-month, 6-month, 9-month, 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2026

Primary Completion (Estimated)

March 11, 2027

Study Completion (Estimated)

March 11, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREC2026KY007ck

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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