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The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.
The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLRL of 100% intensity | Experimental | Participants will be treated with RLRL treatment (100% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period. |
|
| RLRL of 5% intensity | Sham Comparator | Participants will be treated with the sham device (5% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLRL device | Device | Crossover device (RLRL of 5% or 100% intensity - alternate to first group). Cross over arms after one month of use and one month of washout period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in subfoveal choroidal thickness | Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in choroidal vascularity index | Changes in choroidal vascularity index after 1-month RLRL treatment, which is measured by optical coherence tomography. | 1 month |
| Changes in OCTA-derived parameters of the choroid and retina |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Kong, PhD | Contact | +86075788032111 | xiangbin_kong@sina.com | |
| Cong Li, MD | Contact | leoleelc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Kong, PhD | The Second People's Hospital of Foshan, Guangdong Province,China | Study Chair |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Changes in OCTA-derived parameters of the choroid and retina after 1-month RLRL treatment
| 1 month |
| Changes in DR grading | Changes in DR grading after 1-month RLRL treatment | 1 month |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |