MyopiaNCT06717048
Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
A study testing Repeated Low-level Red-light and Red LED in people with Myopia and Refractive Error - Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Error - Myopia, Choroidal Thickness
- What is being tested?
- Repeated Low-level Red-light and Red LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to 9 Jun 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 8-10 years old
- Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
- signed informed consent and was able to participate in the study
Who cannot join
- Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
- Strabismus or other binocular vision abnormalities
- Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
- Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
- diabetes, hypertension and other systemic disorders
Show all 9Show fewer
- History of use of retinal toxic drugs, such as hydroxychloroquine, etc.
- Use of orthokeratology, atropine, multifocal frame glasses and other myopia control methods; children who are currently receiving atropine, orthokeratology, multifocal frame glasses and other myopia control treatment, can be enrolled after 2 weeks of treatment.
- Other reasons considered unsuitable for inclusion by the study physician, including but not limited to other ocular and systemic disease abnormalities
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 & Treatment Center
Shanghai, Shanghai Municipality, 200041
Xiangui He, (86)15000755422, xianhezi@163.com
Kaidi Xiang, (86)19121912898, 1454612964@qq.com
About this study
Official title: An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.
Read the detailed description
Myopia has emerged as a significant public health concern in East Asia. The excessive elongation of the axial length ( AL)of the eye, particularly as myopia progresses to high myopia, is associated with mechanical stretching and thinning of the choroid and sclera. This can lead to vision-threatening complications such as myopic macular degeneration, macular hemorrhage, retinal detachment, cataracts, and glaucoma. Given the serious consequences of high myopia and its associated complications, early and effective prevention and control of myopia become a primary focus in safeguarding visual health and enhancing quality of life.
In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.
- Conditions
- Myopia, Refractive Error - Myopia, Choroidal Thickness, Retina
- Being tested
- Repeated Low-level Red-light, Red LED
- 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
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red LEDDevice
In addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Red light: 2.0 mW/twice daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 2.0 mW/once daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 1.0 mW/twice daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 1.0 mW/once daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 0.5 mW/twice daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 0.5 mW/once daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 0.3 mW/twice daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red light: 0.3 mW/once daily | Experimental | Not described Receives: Device: Repeated Low-level Red-light |
| Red LED: twice daily | Sham comparator | Not described Receives: Device: Red LED |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.
Measured: 1 week, 1, 2, 3 months
Secondary outcomes (8)
The incidence rates (%) of cycloplegic spherical equivalent refraction progressing ≥0.00 D after red light for 3 months measured by the autorefractor
Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).
Measured: 1 week, 1, 2, 3 months
Changes of axial length (mm) after discontinuation of red light for 1 months measured by the IOL master
Change of axial length is characterized as the difference between each follow-up visit and baseline values.
Measured: 4 months
Changes of cycloplegic spherical equivalent refraction (D) after discontinuation of red light for 1 months measured by the autorefractor
Change of cycloplegic spherical equivalent refraction is characterized as the difference between each follow-up visit and baseline values.
Measured: 4 months
Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects.
Measured: 1 week, 1, 2, 3, 4 months
Change in visual acuity (logMAR) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart with standard illumination at a distance of 4 meters is used to measure visual acuity.
Measured: 1 week, 1, 2, 3, 4 months
Changes in choroidal thickness (μm) measured by the swept-source optical coherence tomography and optical coherence tomography angiography
Changes in choroidal thickness (μm) are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on.
Measured: 1 week, 1, 2, 3, 4 months
Changes in the amplitudes of waves (mV) measured by the full-filed electroretinogram
Changes in the amplitudes of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Measured: 1 week, 1, 2, 3, 4 months
Changes in the the latency of waves (ms) measured by the full-filed electroretinogram
Changes in the latecy of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Measured: 1 week, 1, 2, 3, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start9 Dec 2024 (estimated)
- Primary completion9 Apr 2025 (estimated)
- Study completion9 Jun 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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 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
- NCT06717048
- Sponsor's protocol ID
- RLPT-SEPTC-2024
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as open data after proper anonymization.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
- ClinicalTrials.gov ID
- NCT06717048
- Acronym / sponsor ID
- RLPT-SEPTC-2024
- Conditions
- Myopia, Refractive Error - Myopia, Choroidal Thickness, Retina
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 9 Apr 2025 (estimated)
- Study completion
- 9 Jun 2025 (estimated)
- First posted
- 4 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.
To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.
Detailed description
Myopia has emerged as a significant public health concern in East Asia. The excessive elongation of the axial length ( AL)of the eye, particularly as myopia progresses to high myopia, is associated with mechanical stretching and thinning of the choroid and sclera. This can lead to vision-threatening complications such as myopic macular degeneration, macular hemorrhage, retinal detachment, cataracts, and glaucoma. Given the serious consequences of high myopia and its associated complications, early and effective prevention and control of myopia become a primary focus in safeguarding visual health and enhancing quality of life.
In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Red light: 2.0 mW/twice daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 2.0 mW/once daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 1.0 mW/twice daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 1.0 mW/once daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 0.5 mW/twice daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 0.5 mW/once daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 0.3 mW/twice daily | Experimental | Device: Repeated Low-level Red-light |
| Red light: 0.3 mW/once daily | Experimental | Device: Repeated Low-level Red-light |
| Red LED: twice daily | Sham comparator | Device: Red LED |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 8-10 years old
- Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
- signed informed consent and was able to participate in the study
Key exclusion criteria (9 listed)
- Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
- Strabismus or other binocular vision abnormalities
- Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
- Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
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-lightIn addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours. | Device | Red light: 0.3 mW/once daily, Red light: 0.3 mW/twice daily, Red light: 0.5 mW/once daily, Red light: 0.5 mW/twice daily, Red light: 1.0 mW/once daily, Red light: 1.0 mW/twice daily, Red light: 2.0 mW/once daily, Red light: 2.0 mW/twice daily |
| Red LEDIn addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes. | Device | Red LED: twice daily |
Primary outcome
The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master
Time frame: 1 week, 1, 2, 3 months
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.
8 secondary outcomes
The incidence rates (%) of cycloplegic spherical equivalent refraction progressing ≥0.00 D after red light for 3 months measured by the autorefractor
Time frame: 1 week, 1, 2, 3 months
Changes of axial length (mm) after discontinuation of red light for 1 months measured by the IOL master
Time frame: 4 months
Changes of cycloplegic spherical equivalent refraction (D) after discontinuation of red light for 1 months measured by the autorefractor
Time frame: 4 months
Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
Time frame: 1 week, 1, 2, 3, 4 months
Change in visual acuity (logMAR) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Time frame: 1 week, 1, 2, 3, 4 months
Changes in choroidal thickness (μm) measured by the swept-source optical coherence tomography and optical coherence tomography angiography
Time frame: 1 week, 1, 2, 3, 4 months
Changes in the amplitudes of waves (mV) measured by the full-filed electroretinogram
Time frame: 1 week, 1, 2, 3, 4 months
Changes in the the latency of waves (ms) measured by the full-filed electroretinogram
Time frame: 1 week, 1, 2, 3, 4 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 4 Dec 2024.
- Individual participant dataSharing planned: Yes. Data will be shared as open data after proper anonymization.
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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 and Red LED in people with Myopia and Refractive Error - 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 3 inclusion and 9 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 4 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 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 Xiangui He, Prof (+862153555032, hxgcrco@shsyf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master (time frame: 1 week, 1, 2, 3 months). 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 4 Dec 2024.