MyopiaNCT07369804
Study on Safety and Efficacy of Focused LED-Based Red-Light Therapy in Myopic Adults
A study testing fLED-based red-light therapy in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This research project is a prospective, single-arm, open-label pilot study designed to evaluate the efficacy and safety of focused LED-based repeated low-level red-light (fLED-RLRL) therapy in myopic adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia
- What is being tested?
- fLED-based red-light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2025to 31 Jul 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years.
- SE refractions between -0.50 and -6.00 diopters (D)
- Astigmatism of 1.50 D or less.
- Best corrected monocular visual acuity better than 20/20 (Snellen equivalent).
- Willingness to provide written informed consent and comply with the treatment protocol.
Who cannot join
- Strabismus or binocular vision abnormalities in either eye.
- Ocular abnormalities in either eye or other systemic abnormalities.
- Previous or current use of myopia control interventions (e.g., orthokeratology, low-dose atropine, pirenzepine) within the past 6 months.
- History of ocular surgeries (e.g., cataract surgery and LASIK/SMILE).
- Afterimage time > 5 minutes (contraindications to RLRL therapy).
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
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
staff, 85227665111, polyu@polyu.edu.hk
About this study
Official title: Safety and Efficacy of Focused LED-Based Repeated Low-Level Red-Light Therapy in Myopic Adults: A Single-Arm Pilot Study
This research project is a prospective, single-arm, open-label pilot study designed to evaluate the efficacy and safety of focused LED-based repeated low-level red-light (fLED-RLRL) therapy in myopic adults. The primary objective is to assess whether the therapy can increase choroidal thickness and improve choroidal blood flow. The secondary objective is to evaluate the safety and tolerability of red light therapy in adult myopes.
The study will enroll 14 myopic adults aged 18 to 50 years, with spherical equivalent refractions ranging from -0.50 to -6.00 diopters. Participants will receive home-based fLED-RLRL therapy (wavelength 650 ± 10 nm, power 0.20 mW) twice daily for 3 minutes per session, 5 days per week, over a total of 28 days, combined with single-vision spectacles. The fLED red-light device employs a standard LED semiconductor chip integrated with a total internal reflection (TIR) lens and microlenses to deliver a precise and concentrated beam, enabling accurate focusing of light energy on the target area. A video tutorial will be provided to guide device usage, and support from the research team will be available throughout the study.
Read more
Before the treatment, baseline data will be collected from each participant. Baseline and follow-up assessments (days 7, 14, 21, 28) will include comprehensive ophthalmic examinations: visual acuity, intraocular pressure, slit-lamp examination, autorefraction and subjective refraction, optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), and posterior blood flowgraphy. These assessments will monitor structural and functional changes in the retina and choroid, as well as adverse events (e.g., retinal damage, prolonged after-images).
Primary and secondary outcomes will include changes in choroidal thickness, choroidal blood flow, ocular biometric parameters, spherical equivalent refraction, and visual acuity. Additional imaging assessments, such as posterior blood flowgraphy, OCT, and OCTA scans, will also be evaluated.
This pilot study aims to preliminarily explore the safety and efficacy of an fLED red-light therapy system integrated with machine vision for myopia management by analyzing choroidal parameters over a short-term treatment period. By providing a safer alternative to current laser-based therapies, this project seeks to advance the field of myopia treatment, offering a novel solution that aligns with the increasing demand for effective and safe interventions.
- Conditions
- Myopia
- Being tested
- fLED-based red-light therapy
- Keywords
- Myopia, Red-Light Therapy, Light-Emitting Diode
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fLED-based red-light therapyDevice
Eligible subjects will receive fLED-based red-light therapy (650nm, 1500 lux, 0.20mW) administered twice daily (3-minute sessions per treatment, minimum 4-hour interval between sessions) over 5 consecutive weekdays, combined with SVS for a total of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| fLED-based red-light therapy | Experimental | Not described Receives: Device: fLED-based red-light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in choroidal thickness measured by OCT
Optical coherence tomography (OCT) imaging will be performed using the ultra-wide field swept-source OCT system (VG200, SVision Imaging, Ltd., Luoyang, China) to measure subfoveal choroidal thickness (SFCT).
Measured: Choroidal thickness will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Secondary outcomes (5)
Change in axial length (AL) measured by IOLMaster 700
Change in axial length (AL) will be measured by IOLMaster 700 (Carl Zeiss Meditec, Oberkochen, Germany) .
Measured: Axial length will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in Best corrected visual acuity (BCVA) using ETDRS chart
An Early Treatment Diabetic Retinopathy Study (ETDRS) chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will be used to measure distance visual acuity. Best corrected visual acuity (BCVA) will be measured at 4 meters.
Measured: BCVA will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in SE measured by auto-refractor and subjective refraction
Auto-refraction will be conducted using an auto-refractor (KR-8800, Topcon, Tokyo, Japan). The same auto-refractor will be used throughout the study. It will be calibrated before each examination session to ensure there is no equipment drift during the long follow-up process. Subjective refraction will be conducted by a trained optometrist using a phoropter or trial frame and lenses. The same equipment will be used throughout the study. It will be calibrated before each examination session to ensure reliability and accuracy of the refraction results during the long follow-up process.
Measured: SE will be measured on days 28 following treatment initiation.
Change in ocular posterior segment blood flow metrics on the LSFG-NAVI
The Laser Speckle Flowgraphy system (LSFG-NAVI) will be utilized to assess blood flow metrics in the posterior segment of the eye. This method involves capturing and analyzing dynamic changes in speckle patterns created by laser light reflecting off moving blood cells, specifically targeting the retinal and choroidal blood flow.
Measured: Ocular posterior segment blood flow metrics will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in choroidal vascularity index (CVI) measured by OCTA
Change in choroidal vascularity index (CVI) will be assessed by optical coherence tomography angiography (OCTA). OCTA imaging will be performed using the ultra-wide field swept-source OCTA system (VG200, SVision Imaging, Ltd., Luoyang, China). Two imaging sessions will be performed, including a peripapillary scan centered on the optic disc (ONH Angio6*6 512*512 R4 mode) and a perifoveal scan centered on the macula (Angio6*6 512*512 R4 mode), to detect any structural changes in the macula and optic nerve head.
Measured: Change in choroidal vascularity index will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start8 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (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 The Hong Kong Polytechnic UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369804
- Sponsor's protocol ID
- HSEARS20250606001
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Focused LED-Based Repeated Low-Level Red-Light Therapy in Myopic Adults: A Single-Arm Pilot Study
- ClinicalTrials.gov ID
- NCT07369804
- Acronym / sponsor ID
- HSEARS20250606001
- Conditions
- Myopia
- Keywords
- Myopia, Red-Light Therapy, Light-Emitting Diode
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jan 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 research project is a prospective, single-arm, open-label pilot study designed to evaluate the efficacy and safety of focused LED-based repeated low-level red-light (fLED-RLRL) therapy in myopic adults. The primary objective is to assess whether the therapy can increase choroidal thickness and improve choroidal blood flow. The secondary objective is to evaluate the safety and tolerability of red light therapy in adult myopes.
The study will enroll 14 myopic adults aged 18 to 50 years, with spherical equivalent refractions ranging from -0.50 to -6.00 diopters. Participants will receive home-based fLED-RLRL therapy (wavelength 650 ± 10 nm, power 0.20 mW) twice daily for 3 minutes per session, 5 days per week, over a total of 28 days, combined with single-vision spectacles. The fLED red-light device employs a standard LED semiconductor chip integrated with a total internal reflection (TIR) lens and microlenses to deliver a precise and concentrated beam, enabling accurate focusing of light energy on the target area. A video tutorial will be provided to guide device usage, and support from the research team will be available throughout the study.
Before the treatment, baseline data will be collected from each participant. Baseline and follow-up assessments (days 7, 14, 21, 28) will include comprehensive ophthalmic examinations: visual acuity, intraocular pressure, slit-lamp examination, autorefraction and subjective refraction, optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), and posterior blood flowgraphy. These assessments will monitor structural and functional changes in the retina and choroid, as well as adverse events (e.g., retinal damage, prolonged after-images).
Primary and secondary outcomes will include changes in choroidal thickness, choroidal blood flow, ocular biometric parameters, spherical equivalent refraction, and visual acuity. Additional imaging assessments, such as posterior blood flowgraphy, OCT, and OCTA scans, will also be evaluated.
This pilot study aims to preliminarily explore the safety and efficacy of an fLED red-light therapy system integrated with machine vision for myopia management by analyzing choroidal parameters over a short-term treatment period. By providing a safer alternative to current laser-based therapies, this project seeks to advance the field of myopia treatment, offering a novel solution that aligns with the increasing demand for effective and safe interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fLED-based red-light therapy | Experimental | Device: fLED-based red-light therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 years.
- SE refractions between -0.50 and -6.00 diopters (D)
- Astigmatism of 1.50 D or less.
- Best corrected monocular visual acuity better than 20/20 (Snellen equivalent).
- Willingness to provide written informed consent and comply with the treatment protocol.
Key exclusion criteria (5 listed)
- Strabismus or binocular vision abnormalities in either eye.
- Ocular abnormalities in either eye or other systemic abnormalities.
- Previous or current use of myopia control interventions (e.g., orthokeratology, low-dose atropine, pirenzepine) within the past 6 months.
- History of ocular surgeries (e.g., cataract surgery and LASIK/SMILE).
- Afterimage time > 5 minutes (contraindications to RLRL therapy).
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 |
|---|---|---|
| fLED-based red-light therapyEligible subjects will receive fLED-based red-light therapy (650nm, 1500 lux, 0.20mW) administered twice daily (3-minute sessions per treatment, minimum 4-hour interval between sessions) over 5 consecutive weekdays, combined with SVS for a total of 28 days. | Device | fLED-based red-light therapy |
Primary outcome
Changes in choroidal thickness measured by OCT
Time frame: Choroidal thickness will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Optical coherence tomography (OCT) imaging will be performed using the ultra-wide field swept-source OCT system (VG200, SVision Imaging, Ltd., Luoyang, China) to measure subfoveal choroidal thickness (SFCT).
5 secondary outcomes
Change in axial length (AL) measured by IOLMaster 700
Time frame: Axial length will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in Best corrected visual acuity (BCVA) using ETDRS chart
Time frame: BCVA will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in SE measured by auto-refractor and subjective refraction
Time frame: SE will be measured on days 28 following treatment initiation.
Change in ocular posterior segment blood flow metrics on the LSFG-NAVI
Time frame: Ocular posterior segment blood flow metrics will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
Change in choroidal vascularity index (CVI) measured by OCTA
Time frame: Change in choroidal vascularity index will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.
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 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
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 fLED-based red-light therapy in people with Myopia, run by The Hong Kong Polytechnic University 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 5 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 27 Jan 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. 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 Mingguang He (85234002795, mingguang.he@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in choroidal thickness measured by OCT (time frame: Choroidal thickness will be measured on baseline, days 7, 14, 21, and 28 following treatment initiation.). 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 27 Jan 2026.