Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) (IDDMECS)
Macular Edema (Swelling of a particular site of the retina) can become a significant problem for Diabetics undergoing Cataract surgery. And a significant number of people who undergo Cataract surgery each year are diabetics. And when you multiply these two factors together you are left with a significant number of people who do not gain as much vision as their peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and when you follow them up, they don't gain as much vision. This Study aims to prevent such an event from happening and therefore allow Diabetics to gain as much vision as they can from cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of the eye) at the end of cataract extraction to control Macular edema brought about by surgery. The main outcome is the central retina thickness and retinal volume as measured by Optical Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment.
Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial growth factor) actions. Dexamethasone has been used in the eye for decades and is short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x cheaper than the previously mentioned ones and therefore has tremendous benefit for developing countries. We seek an alternative drug that can reduce or prevent Macular edema at a less expensive and safer way.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5T 2S8
- Toronto Western Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diabetic patients for Cataract Surgery with vision of ≤ 20/50 and > grade 3 any cataract type using the Lens Opacities Classification System III. Diabetics included must have at least one microaneurysm in the posterior pole (defined by the Superior and Inferior Arcade).
Exclusion Criteria:
- Without any diabetic retinopathy and those with active uncontrolled proliferative disease
- Retinal disease,other than Diabetes, that can affect macular edema
- Uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma
- Eyes with cataract precluding proper OCT measurement pre-operatively
- Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Control
Diabetics undergoing routine cataract surgery
|
|
实验性的:Treatment
Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery
|
0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Central Retinal Thickness
大体时间:within 3 months after cataract surgery
|
within 3 months after cataract surgery
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Best corrected visual acuity and incidence of laser treatments
大体时间:within 3 months after cataract surgery
|
within 3 months after cataract surgery
|
合作者和调查者
调查人员
- 首席研究员:Michael H Brent, MD, FRCSC、University Health Network, Toronto
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Dexamethasone sodium phosphate的临床试验
-
University of OxfordMahidol Oxford Tropical Medicine Research Unit; Department of Medical Research, Lower Myanmar撤销无并发症的恶性疟疾 | 青蒿素抗性
-
Medicines for Malaria VentureNucleus Network Ltd; Southern Star Research Pty Ltd.完全的
-
Mateon Therapeutics完全的
-
Muhimbili University of Health and Allied SciencesKarolinska Institutet; Uppsala University; The University of Western Australia完全的
-
Sanofi完全的静脉血栓栓塞症美国, 加拿大, 俄罗斯联邦, 乌克兰, 火鸡, 印度, 墨西哥, 埃及, 立陶宛, 哥伦比亚, 秘鲁, 大韩民国, 智利, 白俄罗斯, 中国, 南非