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临床试验/CTRI/2024/03/064417
CTRI/2024/03/064417尚未招募不适用

To assess the efficacy and safety of probing of nasolacrimal duct with Mitomycin-C in adults with primary acquired nasolacrimal duct obstruction.

Dr Vandana Sharma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
improvement in Kraft Crawford scale score of watering of eye and patency of lacrimal duct on syringing

研究概览

简要总结

Adult patients with complaint of watering from eyes usually suffer from blockage of the nasolacrimal duct known as chronic dacryocystitis. the currently accepted gold standard of treatment for this condiotn is dacryocystorhinostomy- a procedure in which a new opening is created in the orbital bones and the lacrimal sac is connected directly to the nasal cavity, bypassing the nasolacrimal duct. however, the procedure is time consuming, uncomfortable for the patient and may need general anaesthesia. the waiting period is long and post operative morbidity is also of significant duration. therefore, office procedures such as probing of the nasolacrimal duct have been explored as these are walk in wallk out procedures and do not need pre or post procedure investigations and hospitalisation. augmentation of probing with mitomycin c irrigation can be done to prevent recurrence of the pathology.

this study is designed to assess the efficacy of probing along with mitomycin c as compared to probing alone in terms of relief of symptoms and prevention of recurrence of disease

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 80.00 Year(s)(—)
性别
All

入选标准

  • •patients having a history of primary epiphora due to NLDO patients who will give written consent for the procedure.

排除标准

  • •• Patient with history of previous trauma, recurrent dacryocystitis, surgery, any other obvious cause for NLDO.
  • •• Any ocular disease leading to hyper-lacrimation such as dry eye, corneal ulcer, ocular foreign bodies, etc.
  • •• Pregnant women and women who will be planning to become pregnant within the next 6 months.

结局指标

主要结局

improvement in Kraft Crawford scale score of watering of eye and patency of lacrimal duct on syringing

时间窗: 1 week | 1 month | 3 months

次要结局

未报告次要终点

研究者

发起方
Dr Vandana Sharma
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vandana Sharma

AIIMS Bathinda

研究点 (1)

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