MyopiaNCT07412678
Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia
A study testing Red light and Single vision spectacle lenses in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial 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 ≤… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Myopia
- What is being tested?
- Red light and Single vision spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2026to 11 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital
Beijing
Kai Cao, 01058265900, anzhen602@163.com
About this study
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.
- Conditions
- Myopia
- Being tested
- Red light, Single vision spectacle lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Single vision spectacle lensesOther
Myopia correction, optic way
| Study group | Role | What they receive |
|---|---|---|
| Red light | Experimental | Not described Receives: Device: Red light |
| control | Placebo comparator | Not described Receives: Other: Single vision spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Sphearical equivalent error
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jie, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412678
- Sponsor's protocol ID
- TREC2026KY007ck
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia
- ClinicalTrials.gov ID
- NCT07412678
- Acronym / sponsor ID
- TREC2026KY007ck
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red light | Experimental | Device: Red light |
| control | Placebo comparator | Other: Single vision spectacle lenses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red lightSubjects 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. | Device | Red light |
| Single vision spectacle lensesMyopia correction, optic way | Other | control |
Primary outcome
Axial length
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Sphearical equivalent error
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red light and Single vision spectacle lenses in people with Myopia, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Cao (01058265900, anzhen602@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: Baseline, 3-month, 6-month, 9-month, 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.