Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Diameter of retinal blood vessels
研究概览
简要总结
The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.
详细描述
Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetes type 1 with moderate diabetic retinopathy/healthy
- •Blood pressure < 135/85 mmHg
排除标准
- •Eye disease (excluding diabetic retinopathy)
- •Kidney disease
- •Liver disease
- •Severe asthma
- •Heart disease
- •Hypertension arterial
- •Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
- •Pregnant and breastfeeding women and women who don't use secure contraception
- •Persons who can't do without contact lens in the treated eye.
研究组 & 干预措施
latanoprost
Medical intervention cross-over
干预措施: Latanoprost, diclofenac and dorzolamide (eyedrops) (Drug)
diclofenac
medical intervention
干预措施: Diclofenac (Drug)
dorzolamide
dorzolamide eyedrops twice daily in one week
干预措施: Dorzolamide (Drug)
结局指标
主要结局
Diameter of retinal blood vessels
时间窗: one year
次要结局
- Influence on retinal blood flow in diabetes(one year)