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| Name | Class |
|---|---|
| Laboratoires Thea | INDUSTRY |
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The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem.
In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them.
Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms.
A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUTROF Group | Experimental | vitamin and DHA supplementation |
|
| MERALUT Group | Placebo Comparator | vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrof | Dietary Supplement | DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| density of the deep capillary plexus in optical coherence tomography angiography (OCTA) | Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| capillary plexus density in OCTA | capillary plexus density | six months |
| area (mm²) of the central avascular zone in OCTA | area (mm² | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Creteil | Créteil | Creteil | 94000 | France |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Meralut | Dietary Supplement | vitamin A, natural flavonoids, lutein and zeaxanthin |
|
| Visual acuity measurement ETDRS | Visual acuity | six months |
| Stage of diabetic retinopathy: minimal, moderate or severe | Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula. Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages).
| six months |
| central retinal thickness (µm) in the 2 groups at 6 months | central retinal thickness | six months |
| cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol | cholesterol leve | six months |
| triglycerid level | triglycerid level | six months |
| glycated haemoglobin (percent) | In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method). Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications. 9% Very high 7% Recommended 5% Normal | six months |
| Diet questionnaire | questionnaire | six months |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |