| CTRI Number |
CTRI/2024/08/071760 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of two different strengths of mitomycin c for treating blocked tear ducts in adults . |
|
Scientific Title of Study
|
: A comparative study of efficacy of 0.02 percent MITOMYCIN-C VS 0.04 percent MITOMYCIN-C
in probing in adults with primary acquired nasolacrimal duct obstruction : A prospective randomized interventional 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 |
Dr Vanam Srinidhi |
| Designation |
Postgraduate student |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Ophthalmology,
ESIC medical college and hospital , sanathnagar, HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India |
| Phone |
7093299398 |
| Fax |
|
| Email |
srinidhivanam1401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Radhika |
| Designation |
Professor, DEPARTMENT OF OPHTHALMOLOGY |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of ophthalmology,
ESIC medical college and hospital , sanathnagar , HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India |
| Phone |
9393828458 |
| Fax |
|
| Email |
radhikam24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Radhika |
| Designation |
Professor , DEPARTMENT OF OPHTHALMOLOGY |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of ophthalmology,
ESIC medical college and hospital , sanathnagar , HYDERABAD , TELANGANA , 500018 , INDIA .
Hyderabad
TELANGANA
500018
India |
| Phone |
9393828458 |
| Fax |
|
| Email |
radhikam24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology , ESIC medical college and hospital , sanathnagar , Hyderabad - 500018 , Telangana , India . |
|
|
Primary Sponsor
|
| Name |
Dr Vanam Srinidhi |
| Address |
Post graduate student , Department of ophthalmology,
ESIC medical college and hospital , Sanathnagar , Hyderabad , Telangana , 500018 , India . |
| Type of Sponsor |
Other [principal investigator] |
|
|
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 Vanam Srinidhi |
ESIC medical college and hospital |
Room number : 5 , Minor OT room , Department of ophthalmology , ESIC medical college and hospital , sanathnagar , Hyderabad, Telangana , 500018 , India .
Hyderabad
TELANGANA |
7093299398
srinidhivanam1401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , ESIC Medical College & Hospital and ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.02 percent MITOMYCIN C |
To evaluate the effectiveness and efficacy of 0.02 % MITOMYCIN C irrigation after probing of nasolacrimal duct in maintaining patency in primary acquired nasolacrimal duct obstruction . |
| Intervention |
0.04 percent MITOMYCIN C |
To evaluate the effectiveness and efficacy of 0.04% MITOMYCIN C irrigation after probing of nasolacrimal duct in maintaining patency in primary acquired nasolacrimal duct obstruction and comparing it with 0.02% MITOMYCIN C in maintaining patency .
After primary evaluation and syringing to confirm obstruction of nasolacrimal duct, probing is done under topical anesthesia in minor OT. Procedure will be completed in 15 to 20 minutes .
Post operative topical steroid drops in tapering doses, antibiotic eye drops , nasal decongestants are prescribed for 6 weeks .
After probing patients are followed up at 1 week , 4 weeks , 3 months , 6 months . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for followup . Patients with proven diagnosis of primary acquired nasolacrimal duct obstruction . |
|
| ExclusionCriteria |
| Details |
Patients with acute dacrocystitis , associated with external fistula
,canalicular obstruction , lid malposition ,punctum agenesis, patients using drugs which
causes punctal stenosis, ocular surface disorders, past history of trauma/probing/surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of subjective symptoms such as watering of eye. |
Patients are followed up at 1 week , 4 weeks , 3 months , 6 months . At each followup , patients are questioned about subjective improvement in symptoms . Patency of nasolacrimal duct is confirmed by syringing . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
20/08/2024 |
| 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="6"
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 is a prospective randomized interventional study to compare the efficacy of 0.02% mitomycin c with 0.04% mitomycin c in adults with primary acquired nasolacrimal duct obstruction . The current treatment modality of dacryocystorhinostomy to bypass the obstructed nasolacrimal duct has excellent outcomes . However , probing of nasolacrimal duct with mitomycin c offers an easy, effective and safe substitute to patients who are poor surgical candidates , elderly patients , patients who do not wish to undergo surgery , for buying time for surgery . Goal is to find which concentration of mitomycin c offers more effective improvement in patients symptoms with less to no side effects . |