Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
(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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Intensity Red Light Therapy | Device | myopia and amblyopia comprehensive treatment instrument red light feeding treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately、1 day、1 month、3 months、6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately、1 day、1 month、3 months、6 months after treatment |
| Choroidal thickness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Shuyu | Contact | +190805155537 | chenshuyu980916@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ma Jin, professor | Professor at Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus) | Recruiting | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39501548 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Optical coherence tomography (OCT) was used for choroidal thickness measurement. |
| 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 . | 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. | 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. | Immediately、1 day、1 month、3 months、6 months after treatment |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided