Pathologic MyopiaNCT07312214
LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia
A study testing LED red light in people with Pathologic Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if LED repeated low-level red light (RLRL) therapy works to treat pathologic myopia in adults. It will also learn about the safety of LED-RLRL. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pathologic Myopia
- What is being tested?
- LED red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 30 Dec 2028
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range: 18 to 55 years old;
- Baseline visual acuity: Best Corrected Visual Acuity (BCVA) ≥ 0.1 (LogMAR ≤ 1.0);
- Meeting the diagnostic criteria for high myopia: Spherical Equivalent (SE) ≤ -6.00 D and Axial Length (AL) ≥ 26.0 mm;
- Meeting one of the following pathological fundus changes:
- Fundus manifestations corresponding to Category 2 (diffuse chorioretinal atrophy), Category 3 (patchy chorioretinal atrophy), or Category 4 (macular atrophy associated with choroidal neovascularization) of the META-PM classification criteria*; (ii) Category 1 of the META-PM classification criteria* complicated with macular schisis; (iii) BCVA < 0.6;
Who cannot join
- Concurrent with other ophthalmic diseases that may affect visual acuity or outcome assessment, including active myopic choroidal neovascularization (CNV) requiring anti-VEGF therapy, macular hole, vitreous hemorrhage, diabetic retinopathy, retinal detachment, retinal vein occlusion, optic neuritis, uveitis, severe cataract, and glaucoma;
- Systemic contraindications: Photosensitive epilepsy, autoimmune diseases (e.g., systemic lupus erythematosus), or pregnant/lactating women; Patients who have undergone intraocular surgery, laser treatment, or ophthalmic medication therapy within 3 months prior to enrollment;
- Patients unable to comply with regular follow-up (e.g., due to remote residence) or with cognitive impairment;
- Opaque refractive media that hinder fundus examination.
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, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
About this study
Official title: A Randomized Controlled Trial of LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia
The goal of this clinical trial is to learn if LED repeated low-level red light (RLRL) therapy works to treat pathologic myopia in adults. It will also learn about the safety of LED-RLRL. The main questions it aims to answer are:
Does LED-RLRL modulate choroidal microcirculation to retard retinal atrophy in pathological myopia? What medical problems do participants have when receiving LED-RLRL therapy? Researchers will compare with a sham device (identical in appearance but delivering <10% of the original device's energy output) to see if LED-RLRL works to treat pathologic myopia.
Read more
Participants will:
Take LED-RLRL or sham LED-RLRL twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
Visit the clinic once every 3 months for checkups and tests. Keep a diary of their symptoms and their visual perception.
Read the detailed description
Pathological myopia (PM) is a major cause of irreversible visual impairment and blindness in adults, characterized by progressive axial elongation, choroidal thinning, impaired choroidal microcirculation, and subsequent retinal atrophy, which currently lacks effective therapeutic interventions. Against this clinical backdrop, this prospective randomized controlled trial is designed to systematically investigate the therapeutic efficacy and safety of LED repeated low-level red light (RLRL) therapy in adult patients with PM. The core research objectives are twofold: first, to verify whether LED-RLRL can modulate choroidal microcirculatory function and thereby retard the progression of retinal atrophy in PM patients, and second, to comprehensively assess the safety profile of long-term LED-RLRL administration by monitoring adverse events. To achieve these goals, the study will adopt a randomized controlled design, where eligible participants will be randomly assigned to either the active treatment group or the sham control group. The active treatment group will receive LED-RLRL therapy, while the control group will be administered interventions using a sham device-this device is identical in appearance and operation mode to the active LED-RLRL device but has an energy output of less than 10% of the original, aiming to exclude the placebo effect. The intervention regimen for both groups is standardized: participants will receive the assigned intervention twice daily, with each session lasting 3 minutes, 5 days per week, for a continuous 12-month course. During the study period, all participants will undergo regular follow-up visits at the clinic every 3 months, where a series of comprehensive assessments will be performed, including but not limited to visual acuity measurement, fundus examination, optical coherence tomography (OCT) for choroidal thickness and retinal structure evaluation, and choroidal blood flow dynamic detection to quantify microcirculatory changes. Additionally, participants will be instructed to maintain a detailed daily diary, recording the occurrence time, duration, and severity of any subjective symptoms (e.g., eye fatigue, photophobia) as well as changes in visual perception (e.g., contrast sensitivity, visual field changes), which will serve as supplementary data for safety monitoring and efficacy evaluation. Collectively, this study is expected to provide high-quality evidence for the clinical application of LED-RLRL in the management of PM by clarifying its regulatory effect on choroidal microcirculation and its role in delaying retinal atrophy, while defining its safety boundaries.
- Conditions
- Pathologic Myopia
- Being tested
- LED red light, Sham LED red light
- Keywords
- repeated low-level red light, LED, myopia, treatment
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED red lightDevice
An LED-RLRL device (Airdoc PBM-LED, Model No.: AI-PBM01, Beijing Airdoc Technology Co., Ltd.) was adopted. It has a working wavelength of 650 nm, with an output power of 1.39 mW at the light source, and the output power is 1.39 mW ± 0.1 mW at a position 30 mm away from the observation window glass.
Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
Sham LED red lightDevice
A sham LED-RLRL device (identical in appearance but delivering <10% of the original device's energy output) .
Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | An LED-RLRL device. Receives: Device: LED red light |
| Control | Sham comparator | A sham LED-RLRL device. Receives: Device: Sham LED red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal vascular density
Measured: From enrollment to the end of treatment at 12 months
Choroidal vessel volume index
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
Choroidal thickness
Measured: From enrollment to the end of treatment at 12 months
Distance between Bruch's membrane and choroidal-scleral interface
Measured: From enrollment to the end of treatment at 12 months
Retinal thickness
Measured: From enrollment to the end of treatment at 12 months
Retinal vascular density
Measured: From enrollment to the end of treatment at 12 months
Proportion of participants developed diffuse chorioretinal atrophy
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start31 Dec 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathologic MyopiaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312214
- Sponsor's protocol ID
- EC-20250506-04
- Status last verified
- May 2026
- First submitted
- 4 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the completion of the study, all individual participant data (IPD), including clinical examination data, demographic information, and other relevant datasets, will be shared upon legitimate and reasonable requests following rigorous anonymization procedures to protect participant privacy.
Publications
Zhang J, Yu J, Wang X, Sun T, Zou YL, Zou H, Xu Y. LED red light for atrophy and microcirculation in pathologic myopia (RAMP): study design and protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Apr 6;16(4):e117063. doi: 10.1136/bmjopen-2026-117063.
PubMed 41942156
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia
- ClinicalTrials.gov ID
- NCT07312214
- Acronym / sponsor ID
- EC-20250506-04
- Conditions
- Pathologic Myopia
- Keywords
- repeated low-level red light, LED, myopia, treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 31 Dec 2025 (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.
The goal of this clinical trial is to learn if LED repeated low-level red light (RLRL) therapy works to treat pathologic myopia in adults. It will also learn about the safety of LED-RLRL. The main questions it aims to answer are:
Does LED-RLRL modulate choroidal microcirculation to retard retinal atrophy in pathological myopia? What medical problems do participants have when receiving LED-RLRL therapy? Researchers will compare with a sham device (identical in appearance but delivering <10% of the original device's energy output) to see if LED-RLRL works to treat pathologic myopia.
Participants will:
Take LED-RLRL or sham LED-RLRL twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
Visit the clinic once every 3 months for checkups and tests. Keep a diary of their symptoms and their visual perception.
Detailed description
Pathological myopia (PM) is a major cause of irreversible visual impairment and blindness in adults, characterized by progressive axial elongation, choroidal thinning, impaired choroidal microcirculation, and subsequent retinal atrophy, which currently lacks effective therapeutic interventions. Against this clinical backdrop, this prospective randomized controlled trial is designed to systematically investigate the therapeutic efficacy and safety of LED repeated low-level red light (RLRL) therapy in adult patients with PM. The core research objectives are twofold: first, to verify whether LED-RLRL can modulate choroidal microcirculatory function and thereby retard the progression of retinal atrophy in PM patients, and second, to comprehensively assess the safety profile of long-term LED-RLRL administration by monitoring adverse events. To achieve these goals, the study will adopt a randomized controlled design, where eligible participants will be randomly assigned to either the active treatment group or the sham control group. The active treatment group will receive LED-RLRL therapy, while the control group will be administered interventions using a sham device-this device is identical in appearance and operation mode to the active LED-RLRL device but has an energy output of less than 10% of the original, aiming to exclude the placebo effect. The intervention regimen for both groups is standardized: participants will receive the assigned intervention twice daily, with each session lasting 3 minutes, 5 days per week, for a continuous 12-month course. During the study period, all participants will undergo regular follow-up visits at the clinic every 3 months, where a series of comprehensive assessments will be performed, including but not limited to visual acuity measurement, fundus examination, optical coherence tomography (OCT) for choroidal thickness and retinal structure evaluation, and choroidal blood flow dynamic detection to quantify microcirculatory changes. Additionally, participants will be instructed to maintain a detailed daily diary, recording the occurrence time, duration, and severity of any subjective symptoms (e.g., eye fatigue, photophobia) as well as changes in visual perception (e.g., contrast sensitivity, visual field changes), which will serve as supplementary data for safety monitoring and efficacy evaluation. Collectively, this study is expected to provide high-quality evidence for the clinical application of LED-RLRL in the management of PM by clarifying its regulatory effect on choroidal microcirculation and its role in delaying retinal atrophy, while defining its safety boundaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: LED red lightAn LED-RLRL device. |
| Control | Sham comparator | Device: Sham LED red lightA sham LED-RLRL device. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range: 18 to 55 years old;
- Baseline visual acuity: Best Corrected Visual Acuity (BCVA) ≥ 0.1 (LogMAR ≤ 1.0);
- Meeting the diagnostic criteria for high myopia: Spherical Equivalent (SE) ≤ -6.00 D and Axial Length (AL) ≥ 26.0 mm;
- Meeting one of the following pathological fundus changes:
Key exclusion criteria (4 listed)
- Concurrent with other ophthalmic diseases that may affect visual acuity or outcome assessment, including active myopic choroidal neovascularization (CNV) requiring anti-VEGF therapy, macular hole, vitreous hemorrhage, diabetic retinopathy, retinal detachment, retinal vein occlusion, optic neuritis, uveitis, severe cataract, and glaucoma;
- Systemic contraindications: Photosensitive epilepsy, autoimmune diseases (e.g., systemic lupus erythematosus), or pregnant/lactating women; Patients who have undergone intraocular surgery, laser treatment, or ophthalmic medication therapy within 3 months prior to enrollment;
- Patients unable to comply with regular follow-up (e.g., due to remote residence) or with cognitive impairment;
- Opaque refractive media that hinder fundus examination.
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 |
|---|---|---|
| LED red lightAn LED-RLRL device (Airdoc PBM-LED, Model No.: AI-PBM01, Beijing Airdoc Technology Co., Ltd.) was adopted. It has a working wavelength of 650 nm, with an output power of 1.39 mW at the light source, and the output power is 1.39 mW ± 0.1 mW at a position 30 mm away from the observation window glass. Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months. | Device | Treatment |
| Sham LED red lightA sham LED-RLRL device (identical in appearance but delivering <10% of the original device's energy output) . Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months. | Device | Control |
Primary outcome
Choroidal vascular density
Time frame: From enrollment to the end of treatment at 12 months
Choroidal vessel volume index
Time frame: From enrollment to the end of treatment at 12 months
5 secondary outcomes
Choroidal thickness
Time frame: From enrollment to the end of treatment at 12 months
Distance between Bruch's membrane and choroidal-scleral interface
Time frame: From enrollment to the end of treatment at 12 months
Retinal thickness
Time frame: From enrollment to the end of treatment at 12 months
Retinal vascular density
Time frame: From enrollment to the end of treatment at 12 months
Proportion of participants developed diffuse chorioretinal atrophy
Time frame: From enrollment to the end of treatment at 12 months
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 15 May 2026.
- Derived from this study: PubMed 41942156Zhang J, Yu J, Wang X, Sun T, Zou YL, Zou H, Xu Y. LED red light for atrophy and microcirculation in pathologic myopia (RAMP): study design and protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Apr 6;16(4):e117063. doi: 10.1136/bmjopen-2026-117063.
- Individual participant dataSharing planned: Undecided. After the completion of the study, all individual participant data (IPD), including clinical examination data, demographic information, and other relevant datasets, will be shared upon legitimate and reasonable requests following rigorous anonymization procedures to protect participant privacy.
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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 LED red light in people with Pathologic Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 5 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: looking for participants now, as of the sponsor's last update on 15 May 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 Yan Xu, MD ((021)62982727, drxuyan_2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal vascular density (time frame: From enrollment to the end of treatment at 12 months). 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?
On the ClinicalTrials.gov record for NCT07312214, which also lists 1 linked publication.
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 15 May 2026.