Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
研究概览
简要总结
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.
详细描述
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.
- DHA concentration in the retina can be modified according to the patient's diet.
- Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control.
- Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy.
- It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
- •Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
- •AV > 6/10
- •One eye included. If both are affected, the eye with the poorer perfusion should be included.
- •Affiliated to a social security scheme
排除标准
- •< 18 years old.
- •Pregnant or breastfeeding woman
- •Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness > 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
- •Hypersensitivity to any of the components of Nutrof or Meralut
- •Taking the antivitamin k
- •Known deficit in G6PD-
- •History of renal lithiasis
- •Kidney failure
- •Immunosuppression
- •Chronic Ethylism
- •History of hepatopathy
- •Intracranial tumor, intracranial hypertension
- •Refusal to participate
- •Patient participating in an intervention study.
结局指标
主要结局
density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
时间窗: six months
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.
次要结局
- cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol(six months)
- Stage of diabetic retinopathy: minimal, moderate or severe(six months)
- central retinal thickness (µm) in the 2 groups at 6 months(six months)
- capillary plexus density in OCTA(six months)
- Visual acuity measurement ETDRS(six months)
- glycated haemoglobin (percent)(six months)
- Diet questionnaire(six months)
- area (mm²) of the central avascular zone in OCTA(six months)
- triglycerid level(six months)