Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema: Anatomical and Functional Outcomes of Treatment and Retreatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Central macular thickness (in microns) (CMT change )
研究概览
简要总结
We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.
详细描述
Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age: 16 or older (Adults)
- •Sex: both
- •NTDME with CMT >300 u
- •< 10% reduction in CMT (than previous treatment)
- •< 50 u reduction in CMT (than previous treatment)
- •Worsening of BCVA > 1 line on E chart.
- •Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
- •Pseudophakic eyes
- •NPDR , PRP-treated PDR
排除标准
- •• Phakic eyes
- •Uncontrolled Glaucoma (IOP > 24 mmHg, or cup disc ratio 0.8 or more)
- •Herpetic viral infection.
- •Untreated PDR
结局指标
主要结局
Change in Central macular thickness (in microns) (CMT change )
时间窗: between baseline and 6 months
Change in Central macular thickness (in microns) (CMT change )
Change in Best corrected visual acuity (BCVA change) )
时间窗: between baseline and 6 months
lines of Change in Best corrected visual acuity (BCVA change) )
次要结局
- Number of DEX injections(between baseline and 6 months)
- Shift to anti-VEGF during follow-up(between baseline and 6 months)
- Duration of follow-up ( months)(between baseline and 6 months)
- CMT change > 200 u(between baseline and 6 months)
- BCVA change >= 2 lines(between baseline and 6 months)
- Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD(between baseline and 6 months)
- CMT change > 100 u(between baseline and 6 months)
研究者
Wael Ahmed Ewais
Associate professor of Ophthalmology Cairo university
Dar El Oyoun Hospital