| CTRI Number |
CTRI/2024/09/074035 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Eye pressure control after 5 years of glaucoma surgery |
|
Scientific Title of Study
|
To assess the long term outcomes of trabeculectomy augmented by injection technique of Mitomycin-C |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JOLLY ROHATGI |
| Designation |
PROFESSOR |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Room number 510, 5th Floor, Department of Ophthalmology, University College of Medical Sciences & GTB Hospital, Delhi-110095
New Delhi
DELHI
110095
India |
| Phone |
9899307901 |
| Fax |
|
| Email |
jollyrohatgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JOLLY ROHATGI |
| Designation |
PROFESSOR |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Room Number 510, 5th floor, Department of Ophthalmology, University College of Medical Sciences & GTB Hospital, Delhi-110095
New Delhi
DELHI
110095
India |
| Phone |
9899307901 |
| Fax |
|
| Email |
jollyrohatgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JOLLY ROHATGI |
| Designation |
PROFESSOR |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
| Address |
Room Number 510, 5th floor, Department of Ophthalmology, University College of Medical Sciences & GTB Hospital, Delhi-110095
DELHI
110095
India |
| Phone |
9899307901 |
| Fax |
|
| Email |
jollyrohatgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Delhi-110095, India |
|
|
Primary Sponsor
|
| Name |
Jolly Rohatgi |
| Address |
University College of Medical Sciences and GTB Hospital, Delhi-110095 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Jolly Rohatgi |
UCMS & GTBH |
Room Number 510, 5th floor, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital, Delhi-110095
East
DELHI |
9899307901
jollyrohatgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur Hospital, Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H404||Glaucoma secondary to eye inflammation, (2) ICD-10 Condition: H403||Glaucoma secondary to eye trauma, (3) ICD-10 Condition: H405||Glaucoma secondary to other eye disorders, (4) ICD-10 Condition: H401||Open-angle glaucoma, (5) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent injection technique of mitomycin C injection of trabeculectomy from March 2017 to May 2018 at this institute |
|
| ExclusionCriteria |
| Details |
Rest all operated glaucoma surgery patients not satisfying the inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. IOP control after 5 years of surgery
2. Progression of Glaucoma
3. Any Long term complications of surgery |
Single |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleb morphology after 5 years of surgery using Indiana Bleb grading system |
Single |
|
|
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)
|
20/09/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
|
Trabeculectomy, glaucoma surgery is known to fail over time due to fibrosis. Hence, to improve the outcomes of the surgery, antifibrotic drug like mitomycin C are used. One of the recent methods used is the injection method of mitomycin C. This study will assess the long term success of trabeculectomy surgery with the injection technique of mitomycin C after 5 years of surgery.
|