| CTRI Number |
CTRI/2024/03/064773 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Dry Eye due to MGD- Conservative treatment v/s Intense Pulsed Light Therapy |
|
Scientific Title of Study
|
Evaluation of Intense Pulsed Light Therapy & Conservative Treatment in Meibomian Gland Disease- A Prospective Observational Comparative 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 |
Tulika Srivastava |
| Designation |
Resident |
| Affiliation |
Centre for Sight Eye Institute Dwarka |
| Address |
diagnostics1 1st floor Centre for Sight Eye Institute Plot no 9 Sector 9 Dwarka Delhi
South West
DELHI
110075
India |
| Phone |
8619381597 |
| Fax |
|
| Email |
tulikasrivastava1009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tulika Chauhan |
| Designation |
Senior Consultant |
| Affiliation |
centre for sight eye institute |
| Address |
exam2 2nd floor Centre for Sight Eye Institute Plot no 9 Sector 9 Dwarka Delhi
South West
DELHI
110075
India |
| Phone |
9535133800 |
| Fax |
|
| Email |
toolika.chauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tulika Chauhan |
| Designation |
Senior Consultant |
| Affiliation |
centre for sight eye institute |
| Address |
Exam2 2nd floor Centre for Sight Eye Institute Plot no 9 Sector 9 Dwarka Delhi
South West
DELHI
110075
India |
| Phone |
9535133800 |
| Fax |
|
| Email |
toolika.chauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Sight Eye Institute
Plot No 9, Dwarka Sector 9, Dwarka, New Delhi, Delhi, 110075 |
|
|
Primary Sponsor
|
| Name |
Tulika Srivastava |
| Address |
Centre for Sight Eye Institute
Plot No 9, Dwarka Sector 9, Dwarka, New Delhi, Delhi, 110075 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for Sight Eye Institute |
Centre for Sight Eye Institute
Plot No 9, Dwarka Sector 9, Dwarka, New Delhi, Delhi, 110075 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tulika Chauhan |
Centre for Sight Eye Institute |
Diagnostic room 1 1st floor
Centre for Sight Eye Institute
Plot No 9, Dwarka Sector 9, Dwarka, New Delhi, Delhi, 110075
South West
DELHI |
9535133800
toolika.chauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre For Sight Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H010||Blepharitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
patients diagnosed with MGD
patients who are known case of MGD |
|
| ExclusionCriteria |
| Details |
age below 18 years
acute ocular infection or inflammation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of meibomian gland function |
4weeks 12weeks 24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms |
1 month 3 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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="2"
Months="0"
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
|
The objective is to assess and compare the efficacy of Intense Pulsed Light therapy and conservative management in improving clinical outcomes for MGD in different patients, focusing on symptom relief, tear film stability, and overall ocular surface health |