To study the role of suprachoroidal triamcinolone acetate injection in patients with diabetic retinopathy and diabetic macular edema
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Improvement in best corrected visual acuity
研究概览
简要总结
Present study will be conducted to assess the effect of SuprachoroidalTriamcinolone Acetate in cessation of progression of diabetic retinopathy anddiabetic macular edema. Eyes of the patients will be randomized intointervention and control group. Intervention eye will receive suprachoroidal injectionof triamcinolone acetate with the help of indigenously designed suprachoroidalneedle. Control eye will receive sham injection. Injections will be given atthe time of presentation and will be repeated at 1 month and 2 months.
Visual recovery will be assessed by early treatment diabetic retinopathyscale (ETDRS) at presentation, 1 month, 2 months, 3 months and 6 months, andresolution of edema will be assessed by OCT at presentation, 1 month and 6months. Fundus fluorescein angiography will be performed at presentation, 1month, 2 months, 3 months and 6 months to assess retinal blood vessels.
Safety of monthly suprachoroidal Triamcinolone Acetate will be assessedby measuring intra ocular pressure, fundus examination, blood sugar levels bothfasting and post prandial, HbA1c at presentation, 1 month, 2 months, 3 monthsand 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate or ready for followup for at least 6 months.
- •All patients of diabetic retinopathy and macular edema on FFA & OCT.
排除标准
- •Patients not willing to participate or ready for followup.
- •Patients with HTN (160/110mmHg) Patients with any ocular infection, raised Intraocular pressure (IOP), anycorneal pathology, thinned sclera, scleritis, staphyloma, or any other anterior segment pathology except Pseudophakic patients.
- •Patients diagnosed of any other retinal or vitreous pathologies except diabetic retinopathy and diabetic macular edema.
- •Diabetic retinopathy old case of Diabetic Macular Edema.
- •Patients having severe, very severe diabetic retinopathy, proliferative diabetic retinopathy and diabetic macular edema.
结局指标
主要结局
Improvement in best corrected visual acuity
时间窗: 0, 1 month, 2 month, 3 month 6 month
次要结局
- Reduction in macular edema(pre intervention 1 month, 6 month)