PACTR202001624880753招募中4 期
The South African Macular oEdema in diabetics study (The SAME Study): A prospective randomized non-inferiority trial
aseer Ally0 个研究点目标入组 120 人开始时间: 2019年12月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •All diabetic patients with confirmed DMO – associated visual impairment and the following:
- •Snellen BCVA = 6/9 (equal and worse than 6/9); AND
- •CFT = 250µm on Heidelberg OCT (quality of OCT must be >20)
排除标准
- •Patients who have previously received treatment for DMO (anti-VEGF; grid laser; or periocular or intravitreal steroids)
- •Macular oedema from any other causes such as vein occlusions, post cataract surgery and uveitis.
- •Patients with media opacities with a poor view of their fundus or poor quality OCT scans.
- •Patients with macular ischaemia on FA
- •Patients with other causes of poor vision such as corneal opacities, cataracts, media opacities, optic nerve dysfunction, retinal detachments and other macular/retinal pathologies.
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