CTRI/2024/11/077476尚未招募3 期
A study on the efficacy of External Dacryocystorhinostomy with and without intraoperative application of Mitomycin-C in patients with primary nasolacrimal duct obstruction
Dr Josephine Moni Sneha1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年12月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- resolution of epiphora post Dacryocystorhinostomy surgery
研究概览
简要总结
This study is a randomized, single blind, parallel group. To use Mitomycin C as an adjunctive to external Dacryocystorhinostomy surgery and comparing with the success rate of conventional external Dacryocystorhinostomy surgery in patients with primary nasolacrimal duct obstruction in a tertiary care hospital in India The primary outcome measures will be resolution of epiphora and free duct syringing post external Dacryocystorhinostomy surgery for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Primary Acquired Nasolacrimal Duct Obstruction.
排除标准
- •Past radiotherapy/chemotherapy Burns in nasolacrimal duct area History of naso-orbital trauma/ sinus surgery Lacrimal sac obstruction due to tumors Dacryolith Fibrotic sac TB/syphilis Deviated Nasal Septum to the same side Nasal polyps Hypertrophied turbinates Nasal Tumors Atrophic rhinitis Active/Chronic rhinosinusitis Revision DCR Pregnancy and lactation Deranged coagulation profile Allergy to mitomycin C Patients with less than 6 months of follow-up after surgery were excluded out of study Patients who did not consent for the enrolment into the study.
结局指标
主要结局
resolution of epiphora post Dacryocystorhinostomy surgery
时间窗: 6 months
次要结局
- free duct syringing post Dacryocystorhinostomy surgery(6 months)
研究者
Dr Josephine Moni Sneha
Regional Institute of Ophthalmology, Egmore
研究点 (1)
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