A comparative study of visual outcome, surgical induced astigmatism, endothelial cell loss after manual small incision cataract surgery by viscoexpression technique vs phacosandwich technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. To assess vision
研究概览
简要总结
THIS IS A COMPARATIVE STUDY OF VISUAL OUTCOME, SURGICAL INDUCED ASTIGMATISM AND CORNEAL ENDOTHELIAL CELL LOSS AFTER MANUAL SMALL INCISION CATARACT SURGERY BY VISCOEXPRESSION TECHNIQUE VERSUS PHACOSANDWICH TECHNIQUE, WHICH WILL BE CONDUCTED ON 140 VOLUNTARY PATIENTS FROM COMMUNITY OUTREACH DEPARTMENT AT SANKARA EYE HOSPITAL, GUNTUR. 140 PATIENTS WILL BE DIVIDED IN TO 2 GROUPS (A AND B) (70 PATIENTS IN EACH). DURING MANUAL SICS, PATIENTS FROM GROUP A, NUCLEUS WILL BE DELIVERED USING VISCOEXPRESSION TECHNIQUE, AND IN PATIENTS FROM GROUP B, NUCLEUS WILL BE DELIVERED USING PHACOSANDWICH TECHNIQUE. WE MEASURE VISUAL OUTCOME, CORNEAL ASTIGMATISM AND CORNEAL ENDOTHELIAL CELL COUNT PRE OPERATIVELY, POST OPERATIVELY ON DAY 1 AND DAY 30. INCIDENCE OF ANY COMPLICATIONS WILL BE NOTED. THE DURATION OF THE STUDY IS 6 MONTHS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with best corrected visual acuity (LogMAR) less than or equals to 6/24
- •Patients with controlled diabetes, hypertension and normal IOP
- •Patients with no other ocular pathology
- •Patients with astigmatism less than 2D.
排除标准
- •Patients with traumatic or complicated cataract
- •Patients with previous ocular surgery
- •Patients with small pupil (less than 6mm)
- •Patients with preoperative endothelial cell count less than 1500 cells/mm2
- •Patients with brown cataract.
结局指标
主要结局
1. To assess vision
时间窗: 1. Preoperative | 2. Post operative day 1 | 3. Post operative day 30
2. To assess astigmatism
时间窗: 1. Preoperative | 2. Post operative day 1 | 3. Post operative day 30
3. To assess corneal endothelial cell count
时间窗: 1. Preoperative | 2. Post operative day 1 | 3. Post operative day 30
次要结局
- To assess complications, if any(1. Post operative day 1)
研究者
Palakala Sukrutha
Sankara eye hospital, Guntur
