Choroidal and Retinal Changes After RLRL Therapy in Diabetes and Diabetic Retinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy

Conditions
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Diabetes Mellitus, Type 2, Diabetic Retinopathy

Intervention / Treatment
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* Device: RLRL device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 35-55 years Diagnosis of type 2 diabetes mellitus No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography Exclusion Criteria: Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm Patients with complications such as DME and retinal detachment History of ocular surgical operations Severe systemic diseases Those who could not cooperate with the examination for any reason Cognitive impairment or mental illness Patients with other ocular diseases

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RLRL of 100% intensity<br>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. | Device: RLRL device<br>* 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.<br>|
| Sham Comparator: RLRL of 5% intensity<br>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. | Device: RLRL device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repeated low-level red-light (RLRL) therapy, Choroidal thickness