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临床试验/CTRI/2025/03/082782
CTRI/2025/03/082782尚未招募Phase 3 4

Comparative study To evaluate pain And surgical outcomes between topical Vs sub Tenons Anaesthesia In Manual Small Incision Cataract Surgery At Tertiary Rural Care Hospital

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
A significant findings between the pain & surgical outcomes between the topical v/s Sub tenon’s anaesthesia in the MSICS is expected.

研究概览

简要总结

The researchers here describe the evaluation of pain & surgical outcomes in the Manual Small Incision Cataract Surgery between the topical versus SubTenon’s anaesthesia. The current study will be conducted for 2 years in the tertiary rural care hospital, Wardha, which is a 2-arm parallel interventional study which will included 56 patients in total (Group topical and Group Sub-Tenon’s anaesthesia). Before the patients undergo the intervention trail the demographic details, will be collected on the proforma & after the surgery the later data (VAS score and the  Post surgery counselling checklist- Cataract surgery) will be collected on the EXCEL sheet & required statistical analysis will be done. A significant findings between the pain & surgical outcomes between the topical v/s Sub tenon’s anaesthesia in the MSICS is expected.

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 75.00 Year(s)(—)
性别
All

入选标准

  • Patients having uncomplicated bilateral or unilateral Senile Cataract with grade 2 to 5 nuclear sclerosis or white cataracts.
  • Patients with no other cause for defective vision other than cataract.
  • Patients with no history of previous ocular surgery in the operating eye.
  • Patients who gave their consent.

排除标准

  • Patients with other ocular pathologies including Complicated, Congenital and Traumatic cataracts, Retinal diseases.
  • Patients having immature cataracts associated with other ocular comorbidities, injury, or surgery
  • Patients having operative complications like nucleus drop, PCR or any systemic disorders.
  • Cases with premature entry or where valve could not be formed properly.

结局指标

主要结局

A significant findings between the pain & surgical outcomes between the topical v/s Sub tenon’s anaesthesia in the MSICS is expected.

时间窗: Assessment will be done after one and half months.

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Suyash Singh

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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