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临床试验/CTRI/2024/06/069482
CTRI/2024/06/069482尚未招募不适用

A comparative study of visual outcome, surgical induced astigmatism, endothelial cell loss after manual small incision cataract surgery by viscoexpression technique vs phacosandwich technique

Sankara eye hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月7日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Palakala Sukrutha

Sankara eye hospital, Guntur

研究点 (1)

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