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临床试验/NCT00849537
NCT00849537Unknown1 期

The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
试验地点
2
主要终点
Macula diameter

研究概览

简要总结

In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery, underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their operation. All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone treatment group (Phaco with PCIOL+IVT). One month after surgery a complete eye examination will be done especially; IOP and endophthalmitis. A 6 month follow-up will be done for these two groups and diabetic retinopathy progression will be checked.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Diabetic patients with non-proliferative diabetic retinopathy and regressed PDR

排除标准

  • Uncontrolled HTN
  • History of glaucoma
  • Active PDR
  • Any ophthalmic operation
  • Renal problem(cr>3)

研究组 & 干预措施

Triamcinolone

Experimental

Injection of intravitreal Triamcinolone

干预措施: Triamcinolone (Drug)

结局指标

主要结局

Macula diameter

时间窗: 6th week, 3, 6 months

次要结局

  • Diabetic retinopathy(6th weeks, 3 and 6 months later)

研究者

研究点 (2)

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