Evaluation of safety and efficacy of conjunctival autograft with adjuvants in comparison to conjunctival limbal autograft technique- A randomised control study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recurrence rates of Pterygium and complications
研究概览
简要总结
Randomised control study conducted over a period of one year including patients aged 20 - 70 years presenting with primary pterygium of any grade. 90 patients will be divided into three groups A B and C by simple randomisation . Group A patients will undergo pterygium excision with conjunctival limbal autograft technique. Group B patients will be treated by pterygium excision with conjunctival autograft and intra operative Mitomycin C. Group C patients will be treated by pterygium excision with conjunctival autograft following pre operative subconjunctival Bevacizumab injection. Patients will be followed up on post operative day one, one week , one month, 3 months, 6 months and one year post surgery. At each follow up patient will be assessed for visual acuity, post surgery complications, including recurrence
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 Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 20- 70 years presenting with primary pterygium of any grade.
排除标准
- •Patients allergic to Anesthetic drugs,Antimetabolites and Anti VEGFs, recurrent pterygium,scleral thinning, Acute inflammatory diseases of the eye,severe dry eye,Pregnancy,Hypertension,Cardiac issues and Coagulopathies,Cranial nerve palsies involving extra ocular muscles,Glaucoma,patients not willing to participate in the study.
结局指标
主要结局
Recurrence rates of Pterygium and complications
时间窗: 1 year
次要结局
未报告次要终点
研究者
Dharani Padam
ESIC Medical College and hospital, Sanathnagar, Hyderabad
