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CTRI Number  CTRI/2024/11/077476 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find the effects of a drug-Mitomycin C in patients undergoing surgery for watering eyes 
Scientific Title of Study   A study on the efficacy of External Dacryocystorhinostomy with and without intraoperative application of Mitomycin-C in patients with primary nasolacrimal duct obstruction 
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 Josephine Moni Sneha 
Designation  Post graduate 
Affiliation  Regional Institute of Ophthalmology, Egmore 
Address  Room 101, Orbit and Oculoplasty Department, Regional Institute of Ophthalmology, Rukmani Lakshmipathi Road, Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9344433176  
Fax    
Email  josephinesneha@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mahalakshmi R.P 
Designation  Assistant Professor 
Affiliation  Regional Institute of Ophthalmology, Egmore 
Address  Room 101, Orbit and Oculoplasty Department, Regional Institute of Ophthalmology, Rukmani Lakshmipathi Road, Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9841988862  
Fax    
Email  maha0103@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Josephine Moni Sneha 
Designation  Post graduate 
Affiliation  Regional Institute of Ophthalmology, Egmore 
Address  Room 101, Orbit and Oculoplasty Department, Regional Institute of Ophthalmology, Rukmani Lakshmipathi Road, Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9344433176  
Fax    
Email  josephinesneha@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr Josephine Moni Sneha, Room 101, Orbit and Oculoplasty Department, Regional Institute of Ophthalmology, Rukmani Lakshmipathi Road, Egmore, Chennai - 600008 
 
Primary Sponsor  
Name  Dr Josephine Moni Sneha 
Address  Room 101, Orbit and Oculoplasty Department, Regional Institute of Ophthalmology, Rukmani Lakshmipathi Road, Egmore, Chennai - 600008 
Type of Sponsor  Other [Self] 
 
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 Josephine Moni Sneha  Regional Institute of Ophthalmology  Room 101, Orbit and Oculoplasty Department, Rukmani Lakshmipathi Road, Egmore, Chennai - 600008
Chennai
TAMIL NADU 		 9344433176

josephinesneha@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Madras Medical College  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  Mitomycin C in External Dacryocystorhinostomy surgery  Application of 0.2 mg/ml Mitomycin C in a cotton tip applicator kept at the osteotomy site for 3 minutes of duration for one time during the External Dacryocystorhinostomy surgery 
Comparator Agent  no treatment   only external dacryocystorhinostomy surgery will be done without using mitomyin C 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with Primary Acquired Nasolacrimal Duct Obstruction  
 
ExclusionCriteria 
Details  Past radiotherapy/chemotherapy
Burns in nasolacrimal duct area
History of naso-orbital trauma/ sinus surgery
Lacrimal sac obstruction due to tumors
Dacryolith
Fibrotic sac
TB/syphilis
Deviated Nasal Septum to the same side
Nasal polyps
Hypertrophied turbinates
Nasal Tumors
Atrophic rhinitis
Active/Chronic rhinosinusitis
Revision DCR
Pregnancy and lactation
Deranged coagulation profile
Allergy to mitomycin C
Patients with less than 6 months of follow-up after surgery were excluded out of study
Patients who did not consent for the enrolment into the study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
resolution of epiphora post Dacryocystorhinostomy surgery  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
free duct syringing post Dacryocystorhinostomy surgery  6 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   Phase 3 
Date of First Enrollment (India)   02/12/2024 
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 Applicable 
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 study is a randomized, single blind, parallel group. To use Mitomycin C as an adjunctive to external Dacryocystorhinostomy surgery and comparing with the success rate of conventional external Dacryocystorhinostomy surgery  in patients with primary nasolacrimal duct obstruction in a tertiary care hospital in India The primary outcome measures will be resolution of epiphora and free duct syringing post external  Dacryocystorhinostomy surgery for a period of 6 months. 
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