| CTRI Number |
CTRI/2024/11/076711 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| 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
|
A study to compare the efficacy of two surgeries for management of early onset primary angle closure glaucoma |
|
Scientific Title of Study
|
Comparative analysis between Phacoemulsification with goniotomy vs Trabeculectomy in management of early onset primary angle closure glaucoma: A Pilot RCT |
| 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 Prannya Arora |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 480, Unit 2 Office, 4th floor, Dr Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9711008166 |
| Fax |
|
| Email |
arora.prannya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Gupta |
| Designation |
Associate Professor Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 707
7th floor
Dr Rajendra Prasad Center for Ophthalmic Sciences
All India Institute of Medical Sciences, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
09910015999 |
| Fax |
|
| Email |
dr.shikhagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prannya Arora |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 480, Unit 2 Office
4th floor
Dr Rajendra Prasad Center for Ophthalmic Sciences
All India Institute of Medical Sciences, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
09711008166 |
| Fax |
|
| Email |
arora.prannya19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Center for Ophthalmic Sciences, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr. Rajendra Prasad Center for Ophthalmic Sciences, AIIMS, New Delhi |
| Address |
Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi -110029 |
| 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 Prannya Arora |
AIIMS, New Delhi |
Room 480, Dr Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi-110029
South
DELHI |
09711008166
arora.prannya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
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 |
Phacoemulsification with goniotomy |
Phacoemulsification is a surgical technique used to extract the lens using ultrasonic power and goniotomy is a minimally invasive glaucoma surgery (MIGS), procedure used to treat glaucoma where opening in trabecular meshwork of eyes (a group of canals that drain the fluid from eye) is made using a 26 gauge needle. In this study phacoemulsification along with goniotomy will be done for management of glaucoma in early onset primary angle closure glaucoma patients. In this pilot study, 50 percent eyes of the sample size diagnosed with EO PACG will be selected after randomization to undergo phacoemulsification of lens with nasal 90 degrees goniotomy. |
| Comparator Agent |
Trabeculectomy |
Trabeculectomy is a surgical procedure where a part of trabecular meshwork of the eye and adjacent structures are removed, and a fistula is created connecting the anterior chamber and subconjunctival space. This allows the aqueous humor to drain out of the eye thereby controlling the intra ocular pressure. In this study, 50 percent eyes from the sample size will be selected after randomization and will undergo trabeculectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years of age and less than 40 years of age
2. PACG patients diagnosed at less than 40 years of age
3. CDR more than 0.7 by 1 with NRR thinning or inter eye asymmetry of more than 0.2 with untreated IOP more than 22 mmhg on more than 2 occasions
4. Presence of glaucomatous visual field changes
5. Eyes where target IOP is not achieved on maximum tolerable medical management i.e. topical or systemic |
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years of age
2. Patients with axial length less than 20.5 mm i.e. nanophthalmos eyes
3. Those with secondary chronic angle closure glaucoma due to trauma, uveitis, neovascularization or increased episcleral venous pressure
4. Any associated anterior or posterior morphologic malformations
5. Eyes with corneal anomalies that might influence IOP measurements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To do a comparative analysis of efficacy outcomes post-surgery between Phacoemulsification with Goniotomy Vs Trabeculectomy in Early Onset Primary Angle Closure Glaucoma in terms of percentage reduction in IOP from the overall baseline via each procedure |
6 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To do a comparative analysis of efficacy outcomes post-surgery between Phacoemulsification with Goniotomy Vs Trabeculectomy in Early Onset Primary Angle Closure Glaucoma in terms of number of medications required for IOP control post-surgery |
6 months post surgery |
| To do a comparative analysis of safety outcomes post surgery between Phacoemulsification with Goniotomy Vs Trabeculectomy in Early Onset Primary Angle Closure Glaucoma in terms of Incidence of eyes developing complications post surgery or requiring secondary surgery |
6 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="6"
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
|
Objectives
Primary
1.
To do a comparative analysis of
efficacy and safety outcomes post-surgery between Phacoemulsification with Goniotomy Vs
Trabeculectomy in Early Onset Primary Angle Closure Glaucoma
Secondary
1.
To find a
correlation between biometric parameters including Lens Vault, Lens Thickness and Anterior Chamber Depth with the surgical
outcome
2.
â To formulate any biometric cutoffs to
perform a particular surgery more safely in these patients
Design- Randomized, Parallel Group, Active Controlled
Methodology-
Patients diagnosed with Early onset Primary Angle Closure Glaucoma who are
willing to participate will be recruited in the study. 50 affected eyes will be
taken up for the study. For the study, patients will be recruited from OPD Dr
R.P. Centre AIIMS or glaucoma clinic.
The
participants will undergo detailed preoperative history taking, clinical
examination for best corrected visual acuity , IOP measured with a Goldman
applanation tonometer, anterior segment examination and corneal diameter
measurement with slit-lamp microscopy, ocular fundus examined with a 90 dioptre
lens, refraction, biometry using
IOLMaster 700, anterior chamber angle examination in the dark using Gonioscopy, Cassia ASOCT for angle parameters and LV,
ultrasound bio-microscopy, Visual field assessment and Severity of Glaucoma
using Andersons Criteria.
Patients will undergo Randomization via computer
generated randomization and will be undertaken for Phacoemulsification with
goniotomy or Trabeculectomy. The patient will be called for follow up on
post-operative day 1, day 7, 1 month, 3 months and 6 months.
Outcome- Primary outcome
parameter will be determined in terms of Percentage
reduction in IOP from the overall baseline via each procedure.
Secondary outcome parameters will be Number of medications used for IOP control
post-surgery and Incidence of eyes developing complications post-surgery or requiring
secondary surgery.
|