Comparative Study on the effectiveness of Combined Cataract Surgery with Intravitreal Bevacizumab Versus Sequential Intravitreal Bevacizumab Followed by Cataract Surgery in Diabetic Macular Edema.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes in Macula using SD – OCT both Qualitative (central macular thickness ) and Quantitatively.
研究概览
简要总结
Treatment for Diabetic Macular Edema is intravitreal injection Anti VEGF. Patients with Diabetic Macular Edema and visually significant cataract are selected.divided into 2 Groups.Group 1 patients treated with combined cataract surgery with injection Anti Bevacizumab in single sitting.Group 2 patients first treated with injection Bevacizumab then followed by cataract surgery ( sequential approach). Outcome: 1. Resolution of Macular Edema measured using OCT Macula scan .2. Visual acuity using snellen chart. To compare effect of both approaches
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic patients with immature cataract with varying levels of diabetic Retinopathy with Diabetic macular edema with or without treated with Pan Retinal Photocoagulation in the past Visual Acuity less than (6/18).
排除标准
- •Catarct due to other causes such as traumatic , developmental, complicated cataract Advanced Diabetic Eye Disease , Vitreous Haemorrhage, Tractional membranes, History of ocular trauma Prior or concomitant surgery such as vitreoretinal surgery , glaucoma surgery in the operated eye, intraoperative complications.
- •History of Uveitis, Presence of any retinal or choroidal disease(such as Retinal Vein Occlusion, Ocular Ischemic Syndrome, and Age related Macular Degeneration) , systemic conditions other than diabetes, that could affect retinal thickness .
结局指标
主要结局
Changes in Macula using SD – OCT both Qualitative (central macular thickness ) and Quantitatively.
时间窗: within 1 week preoperative period,post operatively 14 days, 1 month, 3 month and 6 month.
次要结局
- Visual Acuity using Snellens chart.(1 day, 7 days, 14 days, 30 days, then monthly for 6 months after surgery.)
研究者
Dr CHITRA N
REGIONAL INSTITUTE OF OPHTHALMOLOGY and GOVERNMENT OPHTHALMIC HOSPITAL