MyopiaNCT06753773
Red Light Therapy: Short-term Choroidal and Retinal Changes
A study testing Repeated Low-Level Red-Light in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This research project is a prospective, randomized controlled trial designed to assess the short-term effects of varied red light therapies on the choroidal and retinal structures in adult myopes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Repeated Low-Level Red-Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Dec 2024to 30 Sep 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 40 years.
- Myopic spherical equivalent refraction (SER) between -1.00D to -6.00D in both eyes.
- Best corrected visual acuity (BCVA): 20/20 or greater.
- Informed consent for participation.
Who cannot join
- Anisometropia greater than 1.50D.
- Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.
- Systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.
- Inability to attend regular follow up assessment.
- Undergo RLRL therapy in the past 6 months
- 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.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Staff, 85227665111, polyu@polyu.edu.hk
About this study
Official title: The Short-term Impact of Different Types of Red Light Therapy on Choroid and Retina
This research project is a prospective, randomized controlled trial designed to assess the short-term effects of varied red light therapies on the choroidal and retinal structures in adult myopes. The primary objective is to determine which specific retinal regions or cells are primarily affected by short-term repeated low-level red-light (RLRL) therapy, potentially inducing choroidal thickening. The secondary objective is to assess the safety of different types of red light therapy in adult myopes.
The study will enroll 45 myopic adults aged 18-40 years old as participates. They will be randomly assigned into three RLRL groups: small circle (d=0.30mm), medium circle (d=0.50mm), and annular groups (an inner diameter of 0.50 mm and an outer diameter of 0.70mm) without disclosure of their specific group to maintain study blinding. The groups are differentiated by the size and shape of the light spots formed on the retina but with the same power (0.15 mW with a 4 mm pupil size). The Eyerising Myopia Management Device, modified for this study, will be used to administer RLRL with three different spot patterns, adhering to safety standards to minimize risk and ensure participant safety.
Read more
Before the treatment, baseline data will be collected from each participant. Baseline assessments will consist of demographics information, visual acuity checks, axial length measurements, subjective refraction, slit-lamp examinations, adaptive optics imaging, optical coherence tomography and angiography (OCT \& OCTA), posterior blood flowgraphy, electroretinography (ERG), and the Flicker-plus test. Then participants will undergo daily treatments for 14 days, using the therapy settings of the group to which they have been assigned. The treatment will last for 3 minutes twice a day, with a minimal interval of 4 hours. During the 14-day study period, participants will undergo daily assessments by a series of ophthalmic examinations.
Outcomes measured will track changes in choroidal thickness, electrical activity of the retina, axial length, and best corrected visual acuity, alongside other image reports such as adaptive optics imaging, posterior blood flowgraphy and OCT \& OCTA scans.
This study addresses the gaps in understanding how RLRL therapy affects myopia and aims to identify the retina's high-response areas to red light. By doing so, it hopes to minimize unnecessary exposure and potential damage, enhancing the safety and effectiveness of the therapy.
- Conditions
- Myopia
- Being tested
- Repeated Low-Level Red-Light
- Keywords
- myopia, red light therapy, choroidal, retinal
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Low-Level Red-LightDevice
All participants will receive a video guide of the Repeated Low-Level Red-Light device. Eligible subjects will receive daily treatment for 14 days, with each treatment lasting for 3 minutes twice a day, with a minimal interval of 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | 15 subjects will be recruited in the Standard group, where participants will use the current standard Repeated Low-Level Red-Light device. Receives: Device: Repeated Low-Level Red-Light |
| Other types of red light therapy group | Experimental | These 45 subjects will be randomly assigned into three groups: small circle, medium circle, and annular red light groups without disclosure of their specific group to maintain study blinding. Receives: Device: Repeated Low-Level Red-Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in choroidal thickness measured by OCT
The change in choroidal thickness (ChT) after 14-day of repeated low-level red-light therapy in adult myopes. OCT and OCTA imaging will be performed using the ultra-wide field swept-source OCT/A system (VG200). The macula was scanned using the 12-line radial scan pattern with a resolution of 1024 × 12. Each image will cover an area of 12 × 9 mm centered on the fovea with an average of 4 consecutive scan overlaps. ChT is defined as the perpendicular distance between the outer choroid-sclera margin and the retinal pigment epithelium-Bruch's complex. The average ChT of the whole ETDRS 9 grid and central ChT (an area centered on the fovea with a diameter of 1 mm) was calculated with the built-in software. The VG200 device has been acquired by our team and is available for use.
Measured: Choroidal thickness will be measured every day from enrollment to the end of treatment at 2 weeks.
Secondary outcomes (7)
Change in electrical activity of the retina measured by ERG
A standard full-field ERG and mfREG will be conducted. The full-field ERG includes Dark-adapted 0.01 ERG, Dark-adapted 3.0 ERG, Light-adapted 3.0 ERG, and 30 Hz Flicker ERG. Prior to testing, patients will undergo appropriate dark adaptation for 20 minutes to ensure accurate results for the dark-adapted tests.
Measured: ERG will be carried out on the 7th and 14th days of the study
Change in axial length (AL) measured by IOL Master
IOL Master will be used to measure the AL of both eyes. Five measurements will be taken for each eye. The AL measurement will be based on the mean of these five values if the desired precision (≤0.05 mm) is achieved.
Measured: AL will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in best corrected visual acuity (BCVA)
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. Visual acuity measurement is performed at a distance of 4 meters. BCVA will be measured.
Measured: BCVA will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in adaptive optics imaging
The adaptive optics retinal camera rtx1 system (Imagine Eyes) will be employed for high-resolution imaging of cones and rods cells.
Measured: Adaptive optics imaging assessment will be carried out on the 7th and 14th days of the study.
Change in optical coherence tomography angiography (OCTA) scan
OCT and OCTA imaging will be performed using the ultra-wide field swept-source OCT/A system (VG200). The macula was scanned using the 12-line radial scan pattern with a resolution of 1024 × 12. Each image will cover an area of 12 × 9 mm centered on the fovea with an average of 4 consecutive scan overlaps.
Measured: OCTA assessment will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in posterior blood flowgraphy
The Laser Speckle Flowgraphy system (LSFG-NAVI) will be utilized to assess blood flow 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. The LSFG-NAVI device has been acquired by our team and is available for use.
Measured: The posterior blood flowgraphy will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in flicker-plus test
The Flicker-plus test, part of the AVOT system, quickly identifies losses in rod and cone photoreceptors without extensive dark adaptation by measuring flicker modulation thresholds (FMTs) at five key central vision points. Adaptation times are minimal-15 seconds for cones and 90 seconds for rods. The test protocol follows the methodologies established by Amithavikram et al.
Measured: Flicker-plus test will be carried out on the 7th and 14th days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start22 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT06753773
- Sponsor's protocol ID
- HSEARS20240715002
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Impact of Different Types of Red Light Therapy on Choroid and Retina
- ClinicalTrials.gov ID
- NCT06753773
- Acronym / sponsor ID
- HSEARS20240715002
- Conditions
- Myopia
- Keywords
- myopia, red light therapy, choroidal, retinal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 22 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 31 Dec 2024 (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, randomized controlled trial designed to assess the short-term effects of varied red light therapies on the choroidal and retinal structures in adult myopes. The primary objective is to determine which specific retinal regions or cells are primarily affected by short-term repeated low-level red-light (RLRL) therapy, potentially inducing choroidal thickening. The secondary objective is to assess the safety of different types of red light therapy in adult myopes.
The study will enroll 45 myopic adults aged 18-40 years old as participates. They will be randomly assigned into three RLRL groups: small circle (d=0.30mm), medium circle (d=0.50mm), and annular groups (an inner diameter of 0.50 mm and an outer diameter of 0.70mm) without disclosure of their specific group to maintain study blinding. The groups are differentiated by the size and shape of the light spots formed on the retina but with the same power (0.15 mW with a 4 mm pupil size). The Eyerising Myopia Management Device, modified for this study, will be used to administer RLRL with three different spot patterns, adhering to safety standards to minimize risk and ensure participant safety.
Before the treatment, baseline data will be collected from each participant. Baseline assessments will consist of demographics information, visual acuity checks, axial length measurements, subjective refraction, slit-lamp examinations, adaptive optics imaging, optical coherence tomography and angiography (OCT \& OCTA), posterior blood flowgraphy, electroretinography (ERG), and the Flicker-plus test. Then participants will undergo daily treatments for 14 days, using the therapy settings of the group to which they have been assigned. The treatment will last for 3 minutes twice a day, with a minimal interval of 4 hours. During the 14-day study period, participants will undergo daily assessments by a series of ophthalmic examinations.
Outcomes measured will track changes in choroidal thickness, electrical activity of the retina, axial length, and best corrected visual acuity, alongside other image reports such as adaptive optics imaging, posterior blood flowgraphy and OCT \& OCTA scans.
This study addresses the gaps in understanding how RLRL therapy affects myopia and aims to identify the retina's high-response areas to red light. By doing so, it hopes to minimize unnecessary exposure and potential damage, enhancing the safety and effectiveness of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Device: Repeated Low-Level Red-Light15 subjects will be recruited in the Standard group, where participants will use the current standard Repeated Low-Level Red-Light device. |
| Other types of red light therapy group | Experimental | Device: Repeated Low-Level Red-LightThese 45 subjects will be randomly assigned into three groups: small circle, medium circle, and annular red light groups without disclosure of their specific group to maintain study blinding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 to 40 years.
- Myopic spherical equivalent refraction (SER) between -1.00D to -6.00D in both eyes.
- Best corrected visual acuity (BCVA): 20/20 or greater.
- Informed consent for participation.
Key exclusion criteria (6 listed)
- Anisometropia greater than 1.50D.
- Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.
- Systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.
- Inability to attend regular follow up assessment.
- Undergo RLRL therapy in the past 6 months
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 |
|---|---|---|
| Repeated Low-Level Red-LightAll participants will receive a video guide of the Repeated Low-Level Red-Light device. Eligible subjects will receive daily treatment for 14 days, with each treatment lasting for 3 minutes twice a day, with a minimal interval of 4 hours. | Device | Other types of red light therapy group, Standard group |
Primary outcome
Change in choroidal thickness measured by OCT
Time frame: Choroidal thickness will be measured every day from enrollment to the end of treatment at 2 weeks.
The change in choroidal thickness (ChT) after 14-day of repeated low-level red-light therapy in adult myopes. OCT and OCTA imaging will be performed using the ultra-wide field swept-source OCT/A system (VG200). The macula was scanned using the 12-line radial scan pattern with a resolution of 1024 × 12. Each image will cover an area of 12 × 9 mm centered on the fovea with an average of 4 consecutive scan overlaps. ChT is defined as the perpendicular distance between the outer choroid-sclera margin and the retinal pigment epithelium-Bruch's complex. The average ChT of the whole ETDRS 9 grid and central ChT (an area centered on the fovea with a diameter of 1 mm) was calculated with the built-in software. The VG200 device has been acquired by our team and is available for use.
7 secondary outcomes
Change in electrical activity of the retina measured by ERG
Time frame: ERG will be carried out on the 7th and 14th days of the study
Change in axial length (AL) measured by IOL Master
Time frame: AL will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in best corrected visual acuity (BCVA)
Time frame: BCVA will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in adaptive optics imaging
Time frame: Adaptive optics imaging assessment will be carried out on the 7th and 14th days of the study.
Change in optical coherence tomography angiography (OCTA) scan
Time frame: OCTA assessment will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in posterior blood flowgraphy
Time frame: The posterior blood flowgraphy will be taken every day from enrollment to the end of treatment at 2 weeks.
Change in flicker-plus test
Time frame: Flicker-plus test will be carried out on the 7th and 14th days of the study
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 31 Dec 2024.
- Individual participant dataSharing planned: No
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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 Repeated Low-Level Red-Light in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 inclusion and 6 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 31 Dec 2024. 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 Hong Kong. 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?
Change in choroidal thickness measured by OCT (time frame: Choroidal thickness will be measured every day from enrollment to the end of treatment at 2 weeks.). 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 31 Dec 2024.