| CTRI Number |
CTRI/2024/03/064417 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
probing of nasolacrimal duct and irrigation with Mitomycin-C in adults with primary acquired nasolacrimal duct obstruction: is it effective? |
|
Scientific Title of Study
|
To assess the efficacy and safety of probing of nasolacrimal duct with Mitomycin-C in adults with primary acquired 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 Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of ophthalmology, AIIMS Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
9463671706 |
| Fax |
|
| Email |
dr_vandana_9@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Ophthalmology, AIIMS Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
9463671706 |
| Fax |
|
| Email |
dr_vandana_9@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Ophthalmology AIIMS Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
9463671706 |
| Fax |
|
| Email |
dr_vandana_9@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vandana Sharma |
| Address |
Department of Ophthalmology AIIMS Bathinda |
| Type of Sponsor |
Government medical college |
|
|
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 Vandana Sharma |
AIIMS Bathinda |
Department of Ophthalmology AIIMS Bathinda
Bathinda
PUNJAB |
9463671706
dr_vandana_9@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee aiims bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H045||Stenosis and insufficiency of lacrimal passages, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mitomycin c |
probing of nasolacrimal duct will be done in all cases.
1. followed by irrigation with 1ml of mitomycon c 0.02% solution in case group
2. normal saline irrigation in control group |
| Comparator Agent |
probing of nasolacrimal duct |
comparison between effect of mitomycin c and normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients having a history of primary epiphora due to NLDO
patients who will give written consent for the procedure.
|
|
| ExclusionCriteria |
| Details |
• Patient with history of previous trauma, recurrent dacryocystitis, surgery, any other obvious cause for NLDO.
• Any ocular disease leading to hyper-lacrimation such as dry eye, corneal ulcer, ocular foreign bodies, etc.
• Pregnant women and women who will be planning to become pregnant within the next 6 months.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in Kraft Crawford scale score of watering of eye and patency of lacrimal duct on syringing |
1 week
1 month
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2024 |
| 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 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
|
Adult patients with complaint of watering from eyes usually suffer from blockage of the nasolacrimal duct known as chronic dacryocystitis. the currently accepted gold standard of treatment for this condiotn is dacryocystorhinostomy- a procedure in which a new opening is created in the orbital bones and the lacrimal sac is connected directly to the nasal cavity, bypassing the nasolacrimal duct. however, the procedure is time consuming, uncomfortable for the patient and may need general anaesthesia. the waiting period is long and post operative morbidity is also of significant duration. therefore, office procedures such as probing of the nasolacrimal duct have been explored as these are walk in wallk out procedures and do not need pre or post procedure investigations and hospitalisation. augmentation of probing with mitomycin c irrigation can be done to prevent recurrence of the pathology. this study is designed to assess the efficacy of probing along with mitomycin c as compared to probing alone in terms of relief of symptoms and prevention of recurrence of disease |