| CTRI Number |
CTRI/2025/03/082335 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of efficacy of cataract surgery alone compared to cataract surgery combined with a minimally invasive glaucoma surgery in angle closure glaucoma |
|
Scientific Title of Study
|
Evaluation of efficacy of
phacoemulsification combined
with bent angle needle
goniectomy in primary angle
closure glaucoma |
| 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 Kirti Singh |
| Designation |
Director professor |
| Affiliation |
Director Professor, Guru Nanak eye centre |
| Address |
Guru Nanak Eye Centre, Maulana Azad medical college, Maharaja Ranjeet Singh Marg LNJP Colony New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
01123234622 |
| Fax |
|
| Email |
gnecdir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shireen Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre Maharaja Ranjeet Singh Marg LNJP Colony New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9888534513 |
| Fax |
|
| Email |
shireengupta24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shireen Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre Maharaja Ranjeet Singh Marg LNJP Colony New Delhi 110002
DELHI
110002
India |
| Phone |
9888534513 |
| Fax |
|
| Email |
shireengupta24@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 |
Guru Nanak Eye Centre |
| Address |
Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi, 110002, India |
| 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 Shireen Gupta |
Guru Nanak Eye Centre, Maulana Azad medical college |
Department of Ophthalmology
Division- Glaucoma unit
Room no.- OPD 19
New Delhi
DELHI |
9888534513
shireengupta24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The PG Protocol Committee MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phacoemilsification with Bent Angle Needle Goniectomy |
The study group would undergo phacoemulsification with bent angle needle goniectomy (BANG).The patients will be examined preoperatively, and they will be followed up postoperatively on a schedule of 1 week, 1 month, 3 months, and 6 months. |
| Comparator Agent |
Phacoemulsification |
The control group would undergo phacoemulsification alone. The patients will be examined preoperatively, and they
will be followed up postoperatively on a schedule of 1 week, 1 month, 3 months, and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild-moderate primary angle closure glaucoma with IOP controlled on at least 1 topical
anti glaucoma medication requiring cataract surgery
2. Patent peripheral iridotomy |
|
| ExclusionCriteria |
| Details |
1. Prior intraocular surgery.
2. Prior acute ACG episode.
3. Retinal pathologies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean decrease in intraocular pressure (IOP) at 6 months post Phacoemulsification with bent angle needle
goniectomy (BANG) vs standalone Phacoemulsification. |
1week, 1 month, 3 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the number of anti-glaucoma medications at 6 months post Phacoemulsification with bent
angle needle goniectomy (BANG) vs standalone Phacoemulsification.
Changes in angle parameters on ASOCT (CASIA 2) and 4 mirror Gonioscopy |
1week, 1 month, 3 month, 6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
28/03/2025 |
| 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 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
|
The study population would be randomized into 2 groups A and B (24 each) by the envelope method.The study group would undergo phacoemulsification with bent angle needle goniectomy (BANG) and the control group would undergo phacoemulsification alone. The patients will be examined preoperatively, and they will be followed up postoperatively on a schedule of 1 week, 1 month, 3 months, and 6 months. The reduction in IOP and the number of AGMs would be noted. Patients’ loss to follow-up would be excluded. |