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临床试验/CTRI/2025/04/085537
CTRI/2025/04/085537尚未招募不适用

A prospective study on the effect of Dacryocystectomy on Epiphora and Quality of Life involving 45-60 years age group.

Department of Ophthalmology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To study the effect of Dacryocystectomy (DCT) on epiphora in age group of 45-60 years in cases where Dacryocystorhinostomy is contraindicated.

研究概览

简要总结

INTRODUCTION

BACKGROUND:

Dacryocystectomy is a recognized oculoplastic procedure that involves the complete surgical removal of the lacrimal sac. DCT, initially proposed as a treatment for nasolacrimal duct blockage by Woolhouse in 1724, remained the primary treatment for this issue until Toti advanced Dacryocystorhinostomy (DCR) in 1904 [1]. Despite being infrequently performed globally, it remains significant in situations where DCR is not a viable option. Dacryocystectomy nowadays is done for certain specific indications like malignant lacrimal sac tumors, It is almost always performed through an external skin incision.

Epiphora is the most common sign and the most troublesome symptom of obstruction of lacrimal drainage pathway. Linberg and McCormick (1986) coined the term primary acquired nasolacrimal duct obstruction (PANDO) to describe a nasolacrimal duct (NLD) obstruction caused by inflammation of unknown cause that eventually leads to occlusive fibrosis of the NLD [2]. Epiphora is an annoying symptom of PANDO and can have a great impact on the quality of life [3].

Currently, dacryocystectomy is primarily used for treating tumors of the lacrimal sac. Additional reasons for its use include chronic dacryocystitis, patients with significant systemic comorbidities , deformities of the nose or face, a potential for nasocutaneous fistulas following dacryocystorhinostomy, Wegener granulomatosis, and patients who are anxious or unsuitable for prolonged surgeries while supine. However, multiple studies indicate that dacryocystectomy may be a valid option for patients with nasolacrimal duct obstruction associated with dry eye, ocular scarring pemphigoid, Crohn’s disease, and systemic lupus. These indications imply a need to reassess and reposition this procedure within the existing surgical treatments for the lacrimal drainage system [4].

    RATIONALE:

Dacryocystectomy procedure consists of complete surgical extirpation of the lacrimal sac. Though the procedure does not create a bypass for tear drainage, removal of the lacrimal sac does not allow tear and lacrimal sac mucosal secretions to get accumulated, which can act as a conduit for infection. This not only relieves the patient from recurrent episodes of acute dacryocystitis, but also provides great relief in ocular discharge [5][6]. Alam and Kundu (2022) in their study published in the Indian Journal of Ophthalmology to look for relevance of Dacryocystectomy in reducing epiphora which shows subjective improvement in epiphora following Dacryocystectomy in 86.8% patients. After 6 weeks of surgery, none of them complained of postoperative discharge[7]. The primary aim of all these studies was to mention the effect of DCT on epiphora and Quality of life in patients belonging to age group of 45-60 years, in an era where DCR is commonly done for management of NLD obstruction.

                AIMS AND OBJECTIVES

General Objectives of this study:

·       To study the effect on epiphora in age group of 45-60 years after dacryocystectomy.

 ·       To study the changes in quality of life.

 Specific Objectives of this study:

·       To study the effect of Dacryocystectomy (DCT) on epiphora in age group of 45-60 years in cases where Dacryocystorhinostomy is contraindicated.

 ·       To study the changes in Watery Eye Quality of life after Dacryocystectomy.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
45.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Primary acquired nasolacrimal duct obstruction of age group 45-60 years with associated comorbidities like oculkar cicatricial pemphigoid, crohn disease and systemic lupus erythematosus.
  • Lacrimal sac tumors.
  • Obstruction of common canaliculi.
  • Tuberculosis of the lacrimal sac 5)Chronic Dacryocystitis with atrophic sac (markedly shrunken and fibrosed).
  • Large nasal polyp 7)Enlarged middle turbinate 8)Atrophic rhinitis 9)Rhinosporiodiosis.

排除标准

  • extremes of age group 2)Bilateral epiphora 3)Patients with secondary NLD obstruction 4)previously failed cases of DCR and DCT.
  • patients with lower lid laxity.
  • ocular surface disorders.
  • patients with h/o trauma 8)patients with lacrimal pump failure 9)Acute dacryocystitis.

结局指标

主要结局

To study the effect of Dacryocystectomy (DCT) on epiphora in age group of 45-60 years in cases where Dacryocystorhinostomy is contraindicated.

时间窗: 2 weeks, 6 months and 1 year

次要结局

  • To study the changes in Watery Eye Quality of life after Dacryocystectomy.

研究者

申办方类型
Government medical college

研究点 (1)

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