Efficacy of chevron versus frown incisions and surgically induced astigmatism in Small Incision Cataract Surgery
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- A significant difference is expected in the efficacy of the chevron v/s frown incisions & the resultant surgically induced astigmatism in the small incision cataract surgery.
研究概览
简要总结
The purpose of the study is to know the efficacy of Chevron v/s Frown incision along with the surgically induced astigmatism in the small incision cataract surgery (SICS). 116 patients (58 in each group) [Group C & Group F] who reported to the Department of Ophthalmology, Acharya Vinobha Bhave Rural Hospital, Sawangi taken up in a two-arm parallel interventional study which will be conducted for a time duration of 2 years. The demographic data along with other pre-clinical data will be collected on the proforma. The surgical intervention will be done & the data will be collected on the EXCEL sheet & required statistical test will be carried out. A significant difference is expected in the efficacy of the chevron v/s frown incisions & the resultant surgically induced astigmatism in the small incision cataract surgery.
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
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having uncomplicated bilateral or unilateral senile cataract with grade 2-5 nuclear sclerosis or white cataracts.
- •2.Patients with no other cause for defective vision other than cataract 3.Patients with no history of previous ocular surgeries in the operating eye.
- •4.Patients with preoperative astigmatism less than 1 D.
排除标准
- •1.Patients with ocular pathologies including complicated, congenital and traumatic cataracts.
- •2.Patients with astigmatism with more than 1 D.
- •3.Patients having immature cataracts associated with ocular comorbidities,injury or surgery.
- •4.Patients having operative complications(nucleus drop,PCR) or any systemic disorder(Diabetes, Hypertension).
- •5.Cases with premature entry or where valve cannot be formed properly.
- •6.Patients unwilling to participate in the study.
结局指标
主要结局
A significant difference is expected in the efficacy of the chevron v/s frown incisions & the resultant surgically induced astigmatism in the small incision cataract surgery.
时间窗: 15 days and 1 month
次要结局
未报告次要终点
研究者
Dr Kunal Bhat
Datta Meghe Institute of Higher Education and Research