Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change of Central Macular Thickness
研究概览
简要总结
Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of nonproliferative diabetic retinopathy
- •presence of the cataract (LOCS 2-3)
排除标准
- •other chronic or acute eye diseases
- •hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
- •allergy to salycilates
研究组 & 干预措施
Diclofenac
Patients with diabetic retinopathy having preoperative treatment with diclofenac
干预措施: Perioperative Diclofenac eye-drops administration (Drug)
Placebo
Control group having placebo treatment
干预措施: placebo (Drug)
结局指标
主要结局
Change of Central Macular Thickness
时间窗: -7, 0, 1, 7, 30, 90 days after the cataract surger
The central macular thickness will be measured with OCT machine.
次要结局
- progression of diabetic retinopathy(-7 and 90 days after cataract surgery)
- IL-12 concentration(immediately before cataract surgery)
研究者
Ljubo Znaor
Ophthalmologist
Clinical Hospital Center, Split
