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