MyopiaNCT05871840
Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
An observational study of Myopia, run by Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences.
Trial summary
Myopia has become one of the leading causes of visual impairment globally and brings a heavy burden on the society. Therefore, preventing and controlling the progression of myopia has become an urgent public health issue that needs to be addressed. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Repeated Low-Level Red-Light (RLRL) Therapy
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In this study, the investigators aim to recruit 360 participants aged 7-18 years at 3 study centers from 3 tertiary hospitals in China, stratified by the treatment duration of RLRL therapy including 6 to 12 months (<12 months); 12 to 24 months (< 24 months); 24 to 36 months (< 36 months); and 36 months or more. Thirty participants are recruited at each treatment duration for each study center. Therefore, the minimum number of subjects per study center is 30, and the maximum number of subjects per study center is 120.
Who may be able to join
- Aged 7-18 years old
- Myopia of cycloplegic spherical equivalent refraction (SER) of -1.0D or greater in both of eyes before starting RLRL therapy
- Participants undergo RLRL therapy currently
- With complete examination data before starting RLRL therapy, including visual acuity, axial length and cycloplegic spherical equivalence refraction
- The subject and their guardian voluntarily sign the informed consent form
Who cannot join
- Presence of strabismus, binocular vision abnormalities, other ocular abnormalities in either eye
- Secondary myopia (such as myopia caused by retinopathy of prematurity or other eye diseases in infancy or early childhood) or myopia associated with systemic syndromes (such as Marfan syndrome)
- Presence of other significant ocular and/or systemic diseases or abnormalities
- Medical history of previous eye surgery, laser treatment, or intravitreal injection and so on
- Participants if investigators believe they have contraindications that make them unsuitable for participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Real-World Evidence: Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
Myopia has become one of the leading causes of visual impairment globally and brings a heavy burden on the society. Therefore, preventing and controlling the progression of myopia has become an urgent public health issue that needs to be addressed.
The purpose of this study is to provide real-world evidence for identifying the incidence of myopia control (axial length growth rate ≤ 0.1mm/year) after 36-month RLRL therapy, and long-term safety of RLRL therapy in children and adolescents.
Read the detailed description
The prevalence of myopia in children is increasing worldwide and is viewed as a major public health concern. The current methods for myopia control include medication (e.g., atropine eye drops), optical (e.g., orthokeratology) and environmental interventions (e.g., time outdoors). Nevertheless, these treatments still have limitations. For example, low-concentration atropine may cause systemic side effects and accommodation loss caused by ciliary muscle paralysis. Moreover, the use of orthokeratology in children poses problems such as difficulty wearing, low compliance, and possible complications such as severe corneal infections. Thus, developing the more effective and safe treatment for myopia control in children and adolescents is the future research direction.
Recently, repeated low-level red-light (RLRL) therapy has emerged as a treatment for myopia control in children and adolescents, with promising efficacy and safety. It is suggested that continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression within 2 years. However, relevant information on the effectiveness and safety of RLRL therapy on myopia control over 2 years among children and adolescents remain scarce, which deserves to be further explored.
In this multicenter observational study, the investigators aim to recruit 360 children aged 7-18 years who have currently accepted RLRL therapy at 3 study centers in China. All participants are randomly selected by stratified sampling based on the treatment duration of RLRL therapy (6-12 months, 12-24 months, 24-36 months, 36 months or more). First, the investigators will confirm whether these participants have pre-treatment data (before starting RLRL therapy), including visual acuity, axial length and cycloplegic refraction. Then all the eligible participants who meet the preliminary inclusion criteria, will be invited to come to the corresponding hospitals and further undergo the comprehensive ophthalmic examinations, including visual acuity, measurement of ocular biometric parameters, cycloplegic refraction, slit-lamp examination, color fundus photography, optical coherence tomography (OCT), electroretinography (ERG) and questionnaire surveys.
- Conditions
- Myopia
- Being tested
- Repeated Low-Level Red-Light (RLRL) Therapy
- 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-Light (RLRL) TherapyOther
This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China. This device is certified as a class IIa device by the China National Medical Products Administration. It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus. Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.
| Study group | Role | What they receive |
|---|---|---|
| Treatment duration of RLRL therapy (≥ 6 months and < 12 months) | Not described Receives: Other: Repeated Low-Level Red-Light (RLRL) Therapy | |
| Treatment duration of RLRL therapy (≥12 months and < 24 months) | Not described Receives: Other: Repeated Low-Level Red-Light (RLRL) Therapy | |
| Treatment duration of RLRL therapy (≥24 months and < 36 months) | Not described Receives: Other: Repeated Low-Level Red-Light (RLRL) Therapy | |
| Treatment duration of RLRL therapy (≥36 months) | Not described Receives: Other: Repeated Low-Level Red-Light (RLRL) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of myopia control after 36-month RLRL therapy
Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year
Measured: 36 months or more
Secondary outcomes (8)
Incident visual impairment (logMAR visual acuity < 0.8)
Safety index
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Incident structural damage of the retina and choroid
Safety index
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Change of axial length per year after RLRL therapy.
Validity index
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Change of spherical equivalent refraction per year after RLRL therapy
Validity index
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
The incidence of myopia control after 6-,12- and 24-month RLRL therapy
Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year
Measured: 6-12 months, 12-24 months, 24-36 months
Incident adverse event
Safety index: adverse events including but not limited to dazzling, short-term glare, flash blindness, and delayed afterimages
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Incident severe adverse event
Safety index: including but not limited to sudden visual loss of >2 lines occurring or a scotoma perceived to develop in the center of the visual field.
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Abnormality of the retinal function
Safety index: retinal function is evaluated by electroretinogram (ERG)
Measured: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (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 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, First Hospital Affiliated to Baotou Medical College, Baotou, China
- Responsible party
- Sponsor
- Investigators
- Fang Yu, Principal investigator, Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871840
- Sponsor's protocol ID
- LL-KT-2023006-X1
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as open data after proper anonymization.
Publications
Chen Y, Wang W, Xiong R, Yu F, Pan S, Dong J, Zhang J, Zhu Z, Ding X, Wang B, Chen Y, Chan HH, Choi KY, Chan SSH, Zheng Y, Shi D, Aung Y, Kishi S, Ohno-Matsui K, He M. Three-year efficacy and safety of repeated low-level red-light therapy for myopia control: a multicentre real-world study. Br J Ophthalmol. 2026 Aug 20;110(9):1028-1035. doi: 10.1136/bjo-2025-328687.
PubMed 41558834
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence: Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
- ClinicalTrials.gov ID
- NCT05871840
- Acronym / sponsor ID
- LL-KT-2023006-X1
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shenzhen Hospital (Guangming), University of Chinese Academy of SciencesUniversity, hospital or other
- Collaborators
- the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, First Hospital Affiliated to Baotou Medical College, Baotou, China
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 May 2023 (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.
Myopia has become one of the leading causes of visual impairment globally and brings a heavy burden on the society. Therefore, preventing and controlling the progression of myopia has become an urgent public health issue that needs to be addressed.
The purpose of this study is to provide real-world evidence for identifying the incidence of myopia control (axial length growth rate ≤ 0.1mm/year) after 36-month RLRL therapy, and long-term safety of RLRL therapy in children and adolescents.
Detailed description
The prevalence of myopia in children is increasing worldwide and is viewed as a major public health concern. The current methods for myopia control include medication (e.g., atropine eye drops), optical (e.g., orthokeratology) and environmental interventions (e.g., time outdoors). Nevertheless, these treatments still have limitations. For example, low-concentration atropine may cause systemic side effects and accommodation loss caused by ciliary muscle paralysis. Moreover, the use of orthokeratology in children poses problems such as difficulty wearing, low compliance, and possible complications such as severe corneal infections. Thus, developing the more effective and safe treatment for myopia control in children and adolescents is the future research direction.
Recently, repeated low-level red-light (RLRL) therapy has emerged as a treatment for myopia control in children and adolescents, with promising efficacy and safety. It is suggested that continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression within 2 years. However, relevant information on the effectiveness and safety of RLRL therapy on myopia control over 2 years among children and adolescents remain scarce, which deserves to be further explored.
In this multicenter observational study, the investigators aim to recruit 360 children aged 7-18 years who have currently accepted RLRL therapy at 3 study centers in China. All participants are randomly selected by stratified sampling based on the treatment duration of RLRL therapy (6-12 months, 12-24 months, 24-36 months, 36 months or more). First, the investigators will confirm whether these participants have pre-treatment data (before starting RLRL therapy), including visual acuity, axial length and cycloplegic refraction. Then all the eligible participants who meet the preliminary inclusion criteria, will be invited to come to the corresponding hospitals and further undergo the comprehensive ophthalmic examinations, including visual acuity, measurement of ocular biometric parameters, cycloplegic refraction, slit-lamp examination, color fundus photography, optical coherence tomography (OCT), electroretinography (ERG) and questionnaire surveys.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment duration of RLRL therapy (≥ 6 months and < 12 months) | – | Other: Repeated Low-Level Red-Light (RLRL) Therapy |
| Treatment duration of RLRL therapy (≥12 months and < 24 months) | – | Other: Repeated Low-Level Red-Light (RLRL) Therapy |
| Treatment duration of RLRL therapy (≥24 months and < 36 months) | – | Other: Repeated Low-Level Red-Light (RLRL) Therapy |
| Treatment duration of RLRL therapy (≥36 months) | – | Other: Repeated Low-Level Red-Light (RLRL) Therapy |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In this study, the investigators aim to recruit 360 participants aged 7-18 years at 3 study centers from 3 tertiary hospitals in China, stratified by the treatment duration of RLRL therapy including 6 to 12 months (<12 months); 12 to 24 months (< 24 months); 24 to 36 months (< 36 months); and 36 months or more. Thirty participants are recruited at each treatment duration for each study center. Therefore, the minimum number of subjects per study center is 30, and the maximum number of subjects per study center is 120.
Key inclusion criteria (5 listed)
- Aged 7-18 years old
- Myopia of cycloplegic spherical equivalent refraction (SER) of -1.0D or greater in both of eyes before starting RLRL therapy
- Participants undergo RLRL therapy currently
- With complete examination data before starting RLRL therapy, including visual acuity, axial length and cycloplegic spherical equivalence refraction
- The subject and their guardian voluntarily sign the informed consent form
Key exclusion criteria (5 listed)
- Presence of strabismus, binocular vision abnormalities, other ocular abnormalities in either eye
- Secondary myopia (such as myopia caused by retinopathy of prematurity or other eye diseases in infancy or early childhood) or myopia associated with systemic syndromes (such as Marfan syndrome)
- Presence of other significant ocular and/or systemic diseases or abnormalities
- Medical history of previous eye surgery, laser treatment, or intravitreal injection and so on
- Participants if investigators believe they have contraindications that make them unsuitable for participation.
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-Light (RLRL) TherapyThis treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China. This device is certified as a class IIa device by the China National Medical Products Administration. It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus. Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard. | Other | Treatment duration of RLRL therapy (≥ 6 months and < 12 months), Treatment duration of RLRL therapy (≥12 months and < 24 months), Treatment duration of RLRL therapy (≥24 months and < 36 months), Treatment duration of RLRL therapy (≥36 months) |
Primary outcome
The incidence of myopia control after 36-month RLRL therapy
Time frame: 36 months or more
Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year
8 secondary outcomes
Incident visual impairment (logMAR visual acuity < 0.8)
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Incident structural damage of the retina and choroid
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Change of axial length per year after RLRL therapy.
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Change of spherical equivalent refraction per year after RLRL therapy
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
The incidence of myopia control after 6-,12- and 24-month RLRL therapy
Time frame: 6-12 months, 12-24 months, 24-36 months
Incident adverse event
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Incident severe adverse event
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Abnormality of the retinal function
Time frame: 6-12 months, 12-24 months, 24-36 months, 36 months or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 41558834Chen Y, Wang W, Xiong R, Yu F, Pan S, Dong J, Zhang J, Zhu Z, Ding X, Wang B, Chen Y, Chan HH, Choi KY, Chan SSH, Zheng Y, Shi D, Aung Y, Kishi S, Ohno-Matsui K, He M. Three-year efficacy and safety of repeated low-level red-light therapy for myopia control: a multicentre real-world study. Br J Ophthalmol. 2026 Aug 20;110(9):1028-1035. doi: 10.1136/bjo-2025-328687.
- 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. This study is not recruiting at the moment.
Fang Yu principal investigator
Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences.
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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiong Jiping (18126081918, 377721053@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of myopia control after 36-month RLRL therapy (time frame: 36 months or more). 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 NCT05871840, 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 22 Jun 2023.