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临床试验/NCT04952454
NCT04952454已完成不适用

Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?

Istanbul University4 个研究点 分布在 2 个国家目标入组 135 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
4
主要终点
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.

研究概览

简要总结

135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
接受健康志愿者

入选标准

  • patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)

排除标准

  • Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months

结局指标

主要结局

Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.

时间窗: Last follow-up time, approximately 6 months

次要结局

  • Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.(Last follow-up time, approximately 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Can Ozturker

Asist. Prof.

Istanbul University

研究点 (4)

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