| CTRI Number |
CTRI/2024/06/069127 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| 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
|
Randomised control trial for intraoccular pressure reduction in mild to moderate glaucoma cases |
|
Scientific Title of Study
|
Efficacy of phacoemulsification combined with bent angle needle goniectomy in primary open angle glaucoma cases with visually significant cataract: A randomised control trial. |
| Trial Acronym |
PHACO-BANG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinayak S Gadad |
| Designation |
PG student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Guru Nanak Eye centre
Maharaja Ranjit Singh Marg
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8296422178 |
| Fax |
|
| Email |
dr.vinayaksgadad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinayak S Gadad |
| Designation |
PG student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Guru Nanak Eye centre
Maharaja Ranjit Singh Marg
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8296422178 |
| Fax |
|
| Email |
dr.vinayaksgadad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinayak S Gadad |
| Designation |
PG student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Guru Nanak Eye centre
Maharaja Ranjit Singh Marg
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8296422178 |
| Fax |
|
| Email |
dr.vinayaksgadad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak eye centre
Maharaja Ranjith singh marg
New Delhi -110002
India
delhi 110002
INDIA |
|
|
Primary Sponsor
|
| Name |
Guru Nanak eye center |
| Address |
Guru Nanak Eye Center
Maharaja Ranjith Singh Marg
New Delhi - 110002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinayak S Gadad |
Guru Nanak Eye Center |
ROOM NO 7,OPD BLOCK
Maharaja Ranjit Singh Marg
New Delhi
110002
Central
DELHI |
8296422178
dr.vinayaksgadad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAMC |
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 |
not applicable |
not applicable |
| Intervention |
Randomised control trial |
Efficacy of phacoemulsification combined with bent angle needle goniectomy in primary open angle glaucoma cases with visually significant cataract: A randomised control trial |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Primary open angle glaucoma |
|
| ExclusionCriteria |
| Details |
Secondary Causes of Glaucoma |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Intra ocular pressure and Anti glaucoma medications used. |
1 week,1 month,3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the Angle parameters on gonioscopy & CASIA |
1 week, 1 month, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="0"
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
|
A randomised control trial for intraoccular pressure redution between phacoemulsification combined with bent angle needle goniectomy and Phacoemulsification alone in primary open angle glaucoma cases with visually significant cataract. |