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临床试验/NCT01694212
NCT01694212已完成不适用

Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy

Eye Clinic Medic Zuljan Jukic1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Patients with diabetic retinopathy having preoperative treatment with diclofenac

干预措施: Perioperative Diclofenac eye-drops administration (Drug)

Placebo

Placebo Comparator

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

发起方
Eye Clinic Medic Zuljan Jukic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ljubo Znaor

Ophthalmologist

Clinical Hospital Center, Split

研究点 (1)

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