| CTRI Number |
CTRI/2026/03/105526 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of tear duct blockage using fluoroscopic imaging in patients with chronic dacryocystitis |
|
Scientific Title of Study
|
Fluoroscopic study of Lacrimal apparatus in Patients with Chronic Dacryocystitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chava Sri Vihari |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Otorhinolaryngology, Kasturba medical college, Manipal, Udupi, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9701288233 |
| Fax |
|
| Email |
chavasrivihari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balakrishnan R |
| Designation |
Professor and Head of unit II |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Otorhinolaryngology, Kasturba medical college, Manipal, Udupi, karnataka
KARNATAKA
576104
India |
| Phone |
9845383714 |
| Fax |
|
| Email |
bala.ent@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chava Sri Vihari |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Otorhinolaryngology, Kasturba medical college, Manipal, Udupi, karnataka
KARNATAKA
576104
India |
| Phone |
9701288233 |
| Fax |
|
| Email |
chavasrivihari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology, Kasturba medical college, Manipal, Udupi, karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Balakrishnan R |
| Address |
Department of Otorhinolaryngology, Kasturba medical college, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chava Sri Vihari |
Kasturba medical college and hospital |
Room no-15, Department of Otorhinolaryngology, Outpatient block 4th floor, Manipal, Udupi, Karnataka, India 576104
Udupi
KARNATAKA |
9701288233
chavasrivihari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H044||Chronic inflammation of lacrimal passages, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed chronic dacryocystitis and planned for Endoscopic Dacryocystorhinostomy |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Primary visit, Secondary visit (Post operatively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
16/03/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
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.
|