| CTRI Number |
CTRI/2022/12/048327 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study the outflow pathways of fluid in eye causing rise in eye pressure in Glaucoma patients |
|
Scientific Title of Study
|
Aqueous Angiography: Aqueous humor outflow in patients of Primary Open Angle and Primary Angle Closure Glaucoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanuj Dada |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
Dr. R. P. Centre for Ophthalmic Sciences
AIIMS, New Delhi
AIIMS,Ansari Nagar, Delhi - 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
tanujdada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanuj Dada |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
Dr. R. P. Centre for Ophthalmic Sciences
AIIMS, New Delhi
AIIMS, Ansari Nagar, Delhi- 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
tanujdada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanuj Dada |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
Dr. R. P. Centre for Ophthalmic Sciences
AIIMS, New Delhi
AIIMS, Ansari Nagar, Delhi - 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
tanujdada@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS DELHI |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
AIIMS, Ansari Nagar, 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 |
| Tanuj Dada |
Glaucoma Lab |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
South
DELHI |
01126593001
tanujdada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: H401||Open-angle glaucoma, (3) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Primary Open Angle Glaucoma and Primary Angle Closure Glaucoma with Visually Significant cataract. Patients having Visually significant and no glaucoma. |
|
| ExclusionCriteria |
| Details |
Patients with secondary glaucoma, pregnant or lactating females, patients with iodine or shellfish or indocyanine green dye allergy and patients who do not give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of severity of glaucoma on angiographic signals and patterns of Aqueous Humor Outflow.
|
Cross Sectional Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the Aqueous Humor Outflow pathways with any consistent external sign on conjunctiva or sclera
|
Cross Sectional Study |
| To collect and report normative data of Aqueous Humor Outflow pathways in normal patients, Primary Angle Closure Glaucoma and Primary Open Angle Glaucoma. |
Cross Sectional Study |
Effect of Peripheral Anterior Synechiae on angiographic signals and patterns of Aqueous Humor Outflow.
|
Cross Sectional Study |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
26/12/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No Work Has started on the project currently |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. To assess aqueous humor outflow (AHO) pathways in patients of primary open angle glaucoma (POAG) and primary angle closure glaucoma (PACG) using aqueous angiography. 2. Correlate AHO with severity of glaucoma using aqueous angiography. 3.This study will help in understanding the physiology of AHO pathways which can help clinicians formulate targeted and individualized treatment in different stages of mild, moderate and severe PACG & POAG disease. 4. This study may help identify ways that can enhance intraocular pressure (IOP) reduction by conventional pathways with more consistency using Minimally Invasive Glaucoma Surgery (MIGS) in patients of POAG. 5.This study may help correlate the presence of synechiae on gonioscopy with angiographic patterns and signals in patients of PACG which can help in targeted and individualized management of such patients. |