Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 10
- 主要终点
- The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year, assessed with OCT in the study eye.
研究概览
简要总结
Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.
详细描述
Patients with type 2 diabetes and macular edema involving the center of the macula in both eyes will be randomly assigned to receive conventional treatment in accordance with national guidelines or to receive intensive treatment, with a systematic screening for sleep apnea and /or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected. The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year. Secondary outcomes will be the percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year, number of ocular interventions in each group, prevalence of sleep apnea and uncontrolled high blood pressure in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patient with type 2 diabetes, aged 18 years or more
- •Bilateral diabetic macular edema involving the center of the macula with central retinal thickness 300 µm or more
排除标准
- •Patient with type 1 diabetes
- •Tractional macular edema
- •Patient with renal insufficiency : clearance of creatinin < 30 ml/min according to COCROFT or MDRD, patient under dialysis
- •Other causes for macular edema (uveitis, epiretinal membrane)
- •Proliferative diabetic retinopathy requiring panretinal photocoagulation at inclusion
- •Cataract surgery or panretinal photocoagulation during the 6 months before inclusion, laser photocoagulation at the posterior pole or intra ocular steroid injection during the 3 months before inclusion
- •Any ocular condition precluding access to the posterior pole, or ocular pathologies not related to diabetes (age related macular degeneration venous occlusion...)
- •Previous vitrectomy in the eyes
- •Pregnant or breast-feeding female
结局指标
主要结局
The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year, assessed with OCT in the study eye.
时间窗: M13
次要结局
- Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye(M13)
- Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye(M6-9)
- Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye(M13)
- Comparison of blood pressure in each group at one year(M13)