Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)NCT06034912
Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial
A study testing Low-Intensity Red Light Therapy in people with Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis), run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
1. Research Objective: The primary objective is to investigate the short-term effects of repetitive low-intensity red light therapy on the fundus of the eyes of underage individuals with myopia. 2. Research Design: This experiment employs a prospective, single-center, randomized, controlled clinical research design. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)
- What is being tested?
- Low-Intensity Red Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 31 May 2024
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7~17 years old；
- Spherical equivalent refraction (SER) -1.00 to -5.00D；
- Astigmatism≤ 2.50D；
- Anisometropia (difference between the two equivalent spherical lenses) ≤ 1.50D；
- Best corrected visual acuity (BCVA) in either eye ≥ 20/20；
- Currently willing to use low-intensity red light treatment；
- Be able to understand the purpose of the trial, voluntarily participate and have the subject and his legal guardian sign an informed consent form.
Who cannot join
- strabismus (apparent strabismus) or amblyopia；
- Correction of abnormal vision in either eye；
- Any eye disease that may be related to myopia or affect refractive development, such as history of photosensitivity, macular disease, moderate to severe dry eye, corneal disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve development abnormalities or other eye diseases；
- Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；
- previous history of convulsions, tics, central nervous system underdevelopment, psoriasis, epilepsy and psychiatric and psychological diseases；
- used within 3 months or planned to use low-concentration atropine eye drops during the study；
- Those who have previously used orthokeratology lenses, peripheral defocusing glasses, multifocal soft lenses and other optical therapies to control the progression of myopia, and the elution period is less than three months；
- Other situations in which the investigator believes that the patient is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus)
Guangzhou
Chen Shuyu
About this study
- Research Objective: The primary objective is to investigate the short-term effects of repetitive low-intensity red light therapy on the fundus of the eyes of underage individuals with myopia.
- Research Design: This experiment employs a prospective, single-center, randomized, controlled clinical research design.
- Primary Outcome: Changes in macular sensitivity (microperimetry).
- Recruitment and Participant Information: The study population consists of individuals aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the control group and the experimental group.
- Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact Information: Shuyu Chen, +190805155537, chenshuyu980916@163.com.
Read the detailed description
- Research Design: This study is an interventional research aimed at investigating the short-term effects of repeated low-intensity red light therapy on the fundus of underage individuals with myopia. Retinal light damage typically occurs in the photoreceptor layer and retinal pigment epithelium. Optical coherence tomography angiography (OCTA), OCT, pattern visual evoked potentials (VEP), microperimetry, and multifocal electroretinography (ERG) will be utilized to assess the functionality of the retina, choroid, and optic nerve, thus identifying potential areas of damage. This will provide a scientific basis for further evaluating the safety of low-intensity red light therapy.
- Participant Recruitment: (1) Age range: 7 to 17 years old. (2) Spherical equivalent refraction (SER): -1.00D to -5.00D. (3) Astigmatism: ≤ 2.50D. (4) Anisometropia (difference between the two equivalent spherical lenses): ≤ 1.50D. (5) Best corrected visual acuity (BCVA) in either eye: ≥ 20/20. (6) Willingness to undergo low-intensity red light treatment. (7) Ability to comprehend the trial's purpose, voluntary participation, and signing of an informed consent form by the subject and their legal guardian.
3.Intervention:Control Group: Daily wear of frame glasses for refractive correction, without any additional treatment for myopia control.Experimental Group: Daily wear of frame glasses for refractive correction, along with low-intensity red light therapy as prescribed by the optometrist.
4.Data Collection: All examinations are conducted by experienced doctors，technicians, and optometrists during objective assessments. Data collection forms are incorporated into the medical records. Specialized research coordinators conduct regular follow-up with all subjects via telephone or WeChat.
5.Ethical Review: The trial protocol was developed before the clinical trial commenced and received approval from the ethics committee.
6.Results and Analysis: Data statistical analysis will be performed using SPSS 26.0 statistical software. The Kolmogorov-Smirnov test will be employed for normality distribution testing. Variables following a normal distribution will be expressed as mean ± standard deviation (Mean±SD). Between-group comparisons will be conducted using one-way analysis of variance. Paired t-tests will be used for pre- and post-red light exposure data. Non-normally distributed data will be expressed as median (interquartile range) [M(Q)] and analyzed using rank-sum tests. A significance level of P < 0.05 will indicate statistically significant differences.
7.Safety and Side Effects: None. 8.Discussion and Conclusion: None.
- Being tested
- Low-Intensity Red Light Therapy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Red Light TherapyDevice
myopia and amblyopia comprehensive treatment instrument red light feeding treatment
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Red Light Therapy | Experimental | Intervention method：Daily wearing myopia frame glasses (optical monofocal lenses) and Low-Intensity Red Light therapy during the study to control myopia. Receives: Device: Low-Intensity Red Light Therapy |
| Control group | No intervention | Intervention method: Daily wearing myopia frame glasses (optical monofocal lenses) during the study, no other treatment is used to control myopia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency of P1 waves
Multifocal electroretinogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the latency of P1 wave was recorded.
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Secondary outcomes (5)
Amplitude and latency of P100 waves
Pattern visual evoked potentials (P-VEP) were used to detect the functional integrity of the visual pathway, and the amplitude and latency of the P100 wave were recorded.
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal thickness
Optical coherence tomography (OCT) was used for choroidal thickness measurement.
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal and retinal blood flow density assessment
Optical coherence tomography angiography (OCTA) was used to scan the choroidal and retinal scans of both eyes to check the blood flow density .
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Changes in visual acuity in the macula (microperimetry)
All participants were treated with a microperimetry for fundus imaging and microperimetry examination without mydriasis.
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Amplitude of P1 waves
Multifocal electroretinogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the amplitude of P1 wave (expressed by reaction density) was recorded.
Measured: Immediately、1 day、1 month、3 months、6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start28 Jun 2023
- Primary completion29 Mar 2024 (estimated)
- Study completion31 May 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 Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ma, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Ma Jin, professor, Study chair, Professor at Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034912
- Sponsor's protocol ID
- RLRL RCT
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang Z, Chen S, Wang R, Ma J. Safety of and chorioretinal circulation during repeated low-level red-light therapy for myopic children. Clin Exp Ophthalmol. 2025 Mar;53(2):119-132. doi: 10.1111/ceo.14462. Epub 2024 Nov 5.
PubMed 39501548
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06034912
- Acronym / sponsor ID
- RLRL RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 Sep 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.
- Research Objective: The primary objective is to investigate the short-term effects of repetitive low-intensity red light therapy on the fundus of the eyes of underage individuals with myopia.
- Research Design: This experiment employs a prospective, single-center, randomized, controlled clinical research design.
- Primary Outcome: Changes in macular sensitivity (microperimetry).
- Recruitment and Participant Information: The study population consists of individuals aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the control group and the experimental group.
- Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact Information: Shuyu Chen, +190805155537, chenshuyu980916@163.com.
Detailed description
- Research Design: This study is an interventional research aimed at investigating the short-term effects of repeated low-intensity red light therapy on the fundus of underage individuals with myopia. Retinal light damage typically occurs in the photoreceptor layer and retinal pigment epithelium. Optical coherence tomography angiography (OCTA), OCT, pattern visual evoked potentials (VEP), microperimetry, and multifocal electroretinography (ERG) will be utilized to assess the functionality of the retina, choroid, and optic nerve, thus identifying potential areas of damage. This will provide a scientific basis for further evaluating the safety of low-intensity red light therapy.
- Participant Recruitment: (1) Age range: 7 to 17 years old. (2) Spherical equivalent refraction (SER): -1.00D to -5.00D. (3) Astigmatism: ≤ 2.50D. (4) Anisometropia (difference between the two equivalent spherical lenses): ≤ 1.50D. (5) Best corrected visual acuity (BCVA) in either eye: ≥ 20/20. (6) Willingness to undergo low-intensity red light treatment. (7) Ability to comprehend the trial's purpose, voluntary participation, and signing of an informed consent form by the subject and their legal guardian.
3.Intervention:Control Group: Daily wear of frame glasses for refractive correction, without any additional treatment for myopia control.Experimental Group: Daily wear of frame glasses for refractive correction, along with low-intensity red light therapy as prescribed by the optometrist.
4.Data Collection: All examinations are conducted by experienced doctors，technicians, and optometrists during objective assessments. Data collection forms are incorporated into the medical records. Specialized research coordinators conduct regular follow-up with all subjects via telephone or WeChat.
5.Ethical Review: The trial protocol was developed before the clinical trial commenced and received approval from the ethics committee.
6.Results and Analysis: Data statistical analysis will be performed using SPSS 26.0 statistical software. The Kolmogorov-Smirnov test will be employed for normality distribution testing. Variables following a normal distribution will be expressed as mean ± standard deviation (Mean±SD). Between-group comparisons will be conducted using one-way analysis of variance. Paired t-tests will be used for pre- and post-red light exposure data. Non-normally distributed data will be expressed as median (interquartile range) [M(Q)] and analyzed using rank-sum tests. A significance level of P < 0.05 will indicate statistically significant differences.
7.Safety and Side Effects: None. 8.Discussion and Conclusion: None.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Red Light Therapy | Experimental | Device: Low-Intensity Red Light TherapyIntervention method：Daily wearing myopia frame glasses (optical monofocal lenses) and Low-Intensity Red Light therapy during the study to control myopia. |
| Control group | No intervention | –Intervention method: Daily wearing myopia frame glasses (optical monofocal lenses) during the study, no other treatment is used to control myopia. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 7~17 years old；
- Spherical equivalent refraction (SER) -1.00 to -5.00D；
- Astigmatism≤ 2.50D；
- Anisometropia (difference between the two equivalent spherical lenses) ≤ 1.50D；
- Best corrected visual acuity (BCVA) in either eye ≥ 20/20；
Key exclusion criteria (8 listed)
- strabismus (apparent strabismus) or amblyopia；
- Correction of abnormal vision in either eye；
- Any eye disease that may be related to myopia or affect refractive development, such as history of photosensitivity, macular disease, moderate to severe dry eye, corneal disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve development abnormalities or other eye diseases；
- Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；
- previous history of convulsions, tics, central nervous system underdevelopment, psoriasis, epilepsy and psychiatric and psychological diseases；
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 |
|---|---|---|
| Low-Intensity Red Light Therapymyopia and amblyopia comprehensive treatment instrument red light feeding treatment | Device | Low-Intensity Red Light Therapy |
Primary outcome
Latency of P1 waves
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Multifocal electroretinogram (mfERG) was used to detect the electrophysiological activity of the local retina of the macula, and the latency of P1 wave was recorded.
5 secondary outcomes
Amplitude and latency of P100 waves
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal thickness
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Choroidal and retinal blood flow density assessment
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Changes in visual acuity in the macula (microperimetry)
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Amplitude of P1 waves
Time frame: Immediately、1 day、1 month、3 months、6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 39501548Jiang Z, Chen S, Wang R, Ma J. Safety of and chorioretinal circulation during repeated low-level red-light therapy for myopic children. Clin Exp Ophthalmol. 2025 Mar;53(2):119-132. doi: 10.1111/ceo.14462. Epub 2024 Nov 5.
- Individual participant dataSharing planned: No
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.
Ma Jin, professor study chair
Professor at Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Red Light Therapy in people with Red Laser Light-Induced Retinopathy of Both Eyes (Diagnosis), run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 7 inclusion and 8 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 5 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Shuyu (+190805155537, chenshuyu980916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency of P1 waves (time frame: Immediately、1 day、1 month、3 months、6 months after treatment). 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 NCT06034912, 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 5 Dec 2023.