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)
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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