跳至主要内容
临床试验/CTRI/2026/03/105526
CTRI/2026/03/105526尚未招募不适用

Fluoroscopic study of Lacrimal apparatus in Patients with Chronic Dacryocystitis

Dr Balakrishnan R1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
The primary outcome measures of this study include the identification of the anatomical site of obstruction in the lacrimal drainage system as visualized on fluoroscopic imaging and analysing the outcome of Endoscopic dacryocystorhinostomy surgery.

研究概览

简要总结

Chronic dacryocystitis is a common condition requiring accurate preoperative assessment to ensure optimal surgical outcomes following endoscopic dacryocystorhinostomy. Conventional methods such as syringing may fail to identify partial, functional, or canalicular-level obstructions, potentially leading to surgical failure. Fluoroscopic dacryocystography provides dynamic anatomical and functional assessment of the lacrimal drainage system, enabling precise localization and characterization of obstruction, as well as evaluation of lacrimal sac morphology. Despite its diagnostic utility, limited ENT-based prospective data are available, particularly in Indian tertiary care settings. This study aims to generate evidence on the diagnostic accuracy and clinical relevance of fluoroscopic DCG compared to syringing, thereby improving preoperative planning, predicting surgical outcomes, and potentially reducing failure rates in endoscopic DCR.

Adult patients (18–65 years) with clinically diagnosed chronic dacryocystitis will be included. Participants will undergo standard clinical evaluation including syringing and fluoroscopic DCG using non-ionic contrast (Iohexol). The study will compare syringing and DCG findings, identify the site and type of obstruction, assess lacrimal sac dimensions, and correlate imaging findings with postoperative outcomes following endoscopic DCR. Diagnostic validity will be assessed. The study is observational, does not alter standard treatment.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Patients with clinically diagnosed chronic dacryocystitis and planned for Endoscopic Dacryocystorhinostomy.

排除标准

  • •1.Acute infections of Lacrimal System 2.Patients with allergy to contrast media.
  • •3.Pregnant women 4.Patients with hyperthyroidism or history of thyroid storm, as iodine contrast can exacerbate symptoms 5.Patients with Congenital nasolacrimal duct obstruction 6.Patients with Sinonasal or Orbital Tumors.
  • •7.Lower eyelid malposition including ectropion or entropion.

结局指标

主要结局

The primary outcome measures of this study include the identification of the anatomical site of obstruction in the lacrimal drainage system as visualized on fluoroscopic imaging and analysing the outcome of Endoscopic dacryocystorhinostomy surgery.

时间窗: Primary visit, Secondary visit (Post operatively)

次要结局

  • Evaluation of Transverse and vertical diameters of lacrimal sac to identify fibrotic or non-functional lacrimal sacs.(Primary visit)
  • Comparing between syringing and dacryocystography.(Primary visit)

研究者

发起方
Dr Balakrishnan R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Chava Sri Vihari

Kasturba medical college, Manipal

研究点 (1)

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