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
Not provided
To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLLT(Low Level Laser Therapy) | Device | 2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home |
| Measure | Description | Time Frame |
|---|---|---|
| One-year cumulative incidence of myopia (%) in the intervention group and the control group. | Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The progress of spherical equivalent(SE,D) of children in intervention group and control group. | The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon). | 1 year |
| The progress of axial length of children in intervention group and control group. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiangui He | Shanghai Eye Disease Prevention and Treatment Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangui He | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37099298 | Derived | He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, Chen J, Yang J, Du L, Niu C, Leng M, Huang J, Liu K, Zou H, He M, Xu X. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239612. doi: 10.1001/jamanetworkopen.2023.9612. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2021 | Mar 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2021 | Mar 29, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2021 | Mar 29, 2021 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The axial length will be measured using IOLMaster. |
| 1 year |
| The progress of choroidal thickness in children in pre-myopia state in intervention group and control group. | The choroidal thickness will be measured using SS-OCT. | 1 year |
| The change of uncorrected visual acuity (UCVA) of children in intervention group and control group. | The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts. | 1 year |