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CTRI Number  CTRI/2025/04/085537 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Dacryocystectomy in patients with epiphora and changes in Quality of Life of 45-60 years age group. 
Scientific Title of Study   A prospective study on the effect of Dacryocystectomy on Epiphora and Quality of Life involving 45-60 years age group. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUKANYA SAHA 
Designation  POST GRADUATE TRAINEE 
Affiliation  NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Ophthalmology, Nil Ratan Sircar Medical College and Hospital

Kolkata
WEST BENGAL
700014
India 
Phone  8637581715  
Fax    
Email  sukanyasweet.saha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RUPAM ROY 
Designation  ASSOCIATE PROFESSOR 
Affiliation  NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Ophthalmology, Nil Ratan Sircar Medical College and Hospital

Kolkata
WEST BENGAL
700014
India 
Phone  9830733181  
Fax    
Email  drrupamroy@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  SUKANYA SAHA 
Designation  POST GRADUATE TRAINEE 
Affiliation  NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Ophthalmology, Nil Ratan Sircar Medical College and Hospital

Kolkata
WEST BENGAL
700014
India 
Phone  8637581715  
Fax    
Email  sukanyasweet.saha@gmail.com  
 
Source of Monetary or Material Support  
Principal, Nil Ratan Sircar Medical College and Hospital,Sealdah,Pin-700014,West Bengal,India 
 
Primary Sponsor  
Name  Department of Ophthalmology 
Address  Nil Ratan Sircar Medical College and Hospital 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUKANYA SAHA  Nil Ratan Sircar Medical College and Hospital  Department of Ophthalmology
Kolkata
WEST BENGAL 
8637581715

sukanyasweet.saha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Nil Ratan Sircar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H042||Epiphora,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dacryocystectomy surgery performed for epiphora  The study will be conducted after a voluntary written informed consent. In addition, an interview with Munks scoring system and WEQOL questionnaire will be used to obtain subjective evaluation of epiphora pre and post-dacrocystectomy. The participants will undergo a complete ophthalmic examination which includes syringing,Jones dye test, fluorescein dye disappearance test. The history and examination findings will be recorded in a case record form. All the findings will be noted on a data sheet and tabulated using appropriate software. • After complete preoperative preparation, all the patients underwent Dacryocystectomy under Local Anesthesia.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Primary acquired nasolacrimal duct obstruction of age group 45-60 years with associated comorbidities like oculkar cicatricial pemphigoid, crohn disease and systemic lupus erythematosus.
2)Lacrimal sac tumors.
3)Obstruction of common canaliculi.
4)Tuberculosis of the lacrimal sac
5)Chronic Dacryocystitis with atrophic sac (markedly shrunken and fibrosed).
6)Large nasal polyp
7)Enlarged middle turbinate
8)Atrophic rhinitis
9)Rhinosporiodiosis.
 
 
ExclusionCriteria 
Details  1)extremes of age group
2)Bilateral epiphora
3)Patients with secondary NLD obstruction
4)previously failed cases of DCR and DCT.
5)patients with lower lid laxity.
6)ocular surface disorders.
7)patients with h/o trauma
8)patients with lacrimal pump failure
9)Acute dacryocystitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Dacryocystectomy (DCT) on epiphora in age group of 45-60 years in cases where Dacryocystorhinostomy is contraindicated.
 
2 weeks, 6 months and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To study the changes in Watery Eye Quality of life after Dacryocystectomy.
 
12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.


 
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