FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100823 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A Study of Outcomes of Tear Duct Surgery Using a Nasal Approach 
Scientific Title of Study   Endonasal endoscopic dacryocystorhinostomy and its surgical outcomes: A prospective study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunethra Deve A S 
Designation  POST GRADUATE 
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of ENT,Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Chinnasiragapadi, Salem,Tamil Nadu 636308

Salem
TAMIL NADU
636308
India 
Phone  7358777535  
Fax    
Email  sunethra.ambati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Major Karthikeyan B 
Designation  ASSOCIATE PROFESSOR 
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of ENT,Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Chinnasiragapadi, Salem,Tamil Nadu 636308

Salem
TAMIL NADU
636308
India 
Phone  9626275353  
Fax    
Email  bkn_dr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sunethra Deve A S 
Designation  POST GRADUATE 
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of ENT,Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Chinnasiragapadi, Salem,Tamil Nadu 636308

Salem
TAMIL NADU
636308
India 
Phone  7358777535  
Fax    
Email  sunethra.ambati@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Chinnasiragapadi,Salem,Tamil nadu-636308 
 
Primary Sponsor  
Name  Sunethra Deve A S  
Address  Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Chinnasiragapadi, Salem, Tamil Nadu-636308 
Type of Sponsor  Other [Principal investigator] 
 
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 
Dr Sunethra Deve A S  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL  Department of ENT,Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Chinnasiragapadi, Salem,Tamil Nadu 636308
Salem
TAMIL NADU 		 7358777535

sunethra.ambati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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  Endonasal endoscopic dacryocystorhinostomy  Patients with epiphora due to nasolacrimal duct obstruction will undergo endonasal endoscopic dacryocystorhinostomy under appropriate anesthesia as per standard institutional protocol. Postoperative follow-up at 1 week,1 month,3 months and 6 moths will be done to assess surgical outcomes and complications. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1)Patients of all ages
2)Both males and females
3)Patients with dacryocystitis and mucocele with nasolacrimal duct obstruction.
4)Patients who are willing to undergo diagnostic evaluation and the management. 
 
ExclusionCriteria 
Details  1)Patients who have acute dacryocystitis
2)patients with canalicular block
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Success of endonasal endoscopic dacryocystorhinostomy as assessed by resolution of epiphora and patency of the lacrimal drainage system.  at 3 months post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative complications following endonasal endoscopic dacryocystorhinostomy.During intraoperative & postoperative followup period.
Failure & recurrence rate following endonasal endoscopic dacryocystorhinostomy at final followup. 		 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/02/2026 
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="6"
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   This is a prospective single arm interventional study conducted in the Department of ENT at a tertiary care hospital. Patients presenting with epiphora due to nasolacrimal duct obstruction will be included in the study after obtaining informed consent. All patients will undergo endonasal endoscopic dacryocystorhinostomy as per standard institutional protocol. Patients will be followed up postoperatively and surgical outcomes will be assessed based on resolution of epiphora and patency of the lacrimal drainage system. Postoperative complications and recurrence will also be evaluated during the follow up period. 
Close