| CTRI Number |
CTRI/2024/07/071151 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [preoperative topical steroids on conjunctival histopathology in glaucoma surgery] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of topical steroids on conjunctiva in glaucoma surgery |
|
Scientific Title of Study
|
Evaluation of effect of preoperative topical steroids on conjunctival histopathology in glaucoma surgery |
| 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 Mehak Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony
New Delhi
DELHI
110002
India |
| Phone |
07982518886 |
| Fax |
|
| Email |
mehakg241@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehak Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony
New Delhi
DELHI
110002
India |
| Phone |
07982518886 |
| Fax |
|
| Email |
mehakg241@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehak Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony
New Delhi
DELHI
110002
India |
| Phone |
07982518886 |
| Fax |
|
| Email |
mehakg241@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002, INDIA |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi 110002 |
| 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 Kirti Singh |
Guru Nanak Eye Centre |
Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, 110002
New Delhi
DELHI |
9968604334
gnecdir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Loteprednol etabonate |
Low dose topical steroid will be given for 2 weeks along with topical anti-glaucoma medications prior to glaucoma surgery. |
| Comparator Agent |
NIL |
Patients on topical anti glaucoma medications scheduled for glaucoma surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult primary glaucoma cases requiring trabeculectomy
Patient on 3 or more different classes of topical antiglaucoma medications for a minimum of 3 months duration
|
|
| ExclusionCriteria |
| Details |
Prior incisional surgery involving conjunctiva
Dry eyes requiring more than or equal to two lubricant drops per day, prior herpetic keratitis
Concurrent non-ophthalmic steroid use
Known steroid responder
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conjunctival cellular profile (mean no. of macrophages and other cells) |
1 week, 1 month, 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleb morphology by slit lamp examination (IBAGS) |
1 week, 1 month, 4 months |
| Bleb function by IOP control |
1 week, 1 month, 4 months |
| ASOCT (Anterior Segment Optical Coherence Tomography) for bleb morphology |
1 week, 1 month, 4 months |
|
|
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)
|
16/08/2024 |
| 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="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
|
This is a randomised controlled trial to determine effect of preoperative topical
low dose steroids on conjunctival histopathology
markers for macrophages and other cells. The secondary outcomes measure the effect of preoperative topical
low dose steroids on outcome of glaucoma surgery with respect to
bleb morphology (clinical and ASOCT)
and IOP at 4 months.
|