| 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 |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
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Effect of Dacryocystectomy in patients with epiphora and changes in Quality of Life of 45-60 years age group. |
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Scientific Title of Study
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A prospective study on the effect of Dacryocystectomy on Epiphora and Quality of Life involving 45-60 years age group. |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| Principal, Nil Ratan Sircar Medical College and Hospital,Sealdah,Pin-700014,West Bengal,India |
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Primary Sponsor
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| Name |
Department of Ophthalmology |
| Address |
Nil Ratan Sircar Medical College and Hospital |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
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India |
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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 |
|
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H042||Epiphora, |
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Intervention / Comparator Agent
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| 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 |
|
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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.
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| 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
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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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 |
|
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Secondary Outcome
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| Outcome |
TimePoints |
To study the changes in Watery Eye Quality of life after Dacryocystectomy.
|
12 months |
|
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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" |
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Phase of Trial
|
N/A |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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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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