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临床试验/ISRCTN18293240
ISRCTN18293240进行中(未招募)未知

Optimised treatment for pre-existing Diabetic Macular oEdema during CATaract surgery – a randomised controlled trial (ODMECAT)

Chinese University of Hong Kong0 个研究点目标入组 92 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
92

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged =18 years
  • 2. Type 2 diabetes mellitus
  • 3. Visually significant cataract requiring surgery
  • 4. Centre-involving DME at the time of study enrolment
  • 5. Written informed consent

排除标准

  • 1. History of intravitreal injection of anti-Vascular Endothelial Growth Factor (anti-VEGF) within 1 month, steroids within 3 months, or macular focal/grid laser within 3 months, prior to cataract surgery
  • 2. Macular oedema from causes other than diabetic maculopathy
  • 3. Proliferative diabetic retinopathy requiring treatment, media opacities which affect fundus examination or Optical Coherence Tomography (OCT) measurements at baseline, or known significant macular ischemia demonstrated on fluorescein angiography or OCTA
  • 4. Pre-existing glaucoma at the time of enrolment or previous history of steroid response (Intraocular Pressure (IOP) elevation >35 mmHg following steroid treatment)
  • 5. Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity (including retinal detachment, age-related macular degeneration, pathologic myopia, lamellar macular hole, and epiretinal membrane of the macula)
  • 6. History of hypersensitivity to any intravitreal drugs
  • 7. History of stroke or myocardial infarction within the 6 months prior to the screening visit
  • 8. Pregnant or lactating

研究者

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