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临床试验/ACTRN12615000118505
ACTRN12615000118505招募中2 期

Intra-operative administration of dexamethasone intravitreal implants (Ozurdex) versus intravitreal Bevacizumab during cataract surgery for improving visual outcomes in the management of diabetic maculopathy in Central Australia.

Alice Springs Hospital0 个研究点目标入组 40 人开始时间: 2015年2月10日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Adult patients treated by the Central Australian & Barkly Integrated Eye Health Service, who fit either of the following 2 treatment groups:
  • A. Patients with active DME (defined as macular involving DR, with retinal thickening as assessed on clinical examination), or
  • B. Patients with diabetic retinopathy without active DME
  • - Participants must have significant lens opacity (more than grade 3 for any type of cataract) and scheduled to undergo cataract surgery at the time of enrolment into the study.
  • - Participants must have reduced vision (BCVA impaired to at least the level of (6/9)) in the eye included for the study.

排除标准

  • - Prior intervention in the affected eye, including intravitreal anti-VEGF injections within the last 6 weeks, laser within the last 3 months, or Intravitreal triamcinolone within the last 6 months of time of surgery.
  • - History of open-angle glaucoma or steroid induced IOP elevation that required IOP-lowering treatment, or, IOP greater than or equal to 25.
  • - Eyes with concurrent ocular pathology other than DME causing visual loss.
  • - Patients under the age of 18.

研究者

发起方
Alice Springs Hospital

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