| CTRI Number |
CTRI/2024/02/062360 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Early detection of GLAUCOMA with newer technologies such as visual field testing and OCT angiography photos |
|
Scientific Title of Study
|
A quantitative comparison of Foveal Avascular Zone between glaucomatous and healthy Indian eyes on OCT angiography and its correlation with visual fields. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasad Gaiee |
| Designation |
Junior Resident |
| Affiliation |
Centre for sight B 5 24 Safdarjung enclave , New Delhi |
| Address |
Basement floor Centre for sight B 5 24 Safdarjung enclave New Delhi
South West
DELHI
110029
India |
| Phone |
9011121121 |
| Fax |
|
| Email |
prasadgaiee2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JKS Parihar |
| Designation |
Head of academic |
| Affiliation |
Centre for sight B5 24 Safdarjung enclave New Delhi |
| Address |
Centre for sight B 5 24 Safdarjung enclave New Delhi
South West
DELHI
110029
India |
| Phone |
9818992191 |
| Fax |
|
| Email |
jksparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JKS PARIHAR |
| Designation |
Head of academic |
| Affiliation |
Centre for sight B 5 24 Safdarjung enclave New Delhi |
| Address |
Centre for sight B 5 24 Safdarjung enclave New Delhi
South West
DELHI
110029
India |
| Phone |
9818992191 |
| Fax |
|
| Email |
jksparihar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for sight , B-5/24 Safdarjung enclave, New delhi |
|
|
Primary Sponsor
|
| Name |
Prasad Gaiee |
| Address |
Old Khetan nagar Kaulkhed Akola |
| Type of Sponsor |
Other [Self] |
|
|
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 JKS Parihar |
Centre for Sight |
Room no 115 basement floor centre for sight B 5 24 opposite deer park safdarjung enclave new delhi
South West
DELHI |
9818992191
jksparihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre For Sight Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with primary open angle glaucoma
2) Patients with non glaucomatous healthy eyes acting as control
group |
|
| ExclusionCriteria |
| Details |
1. Patients with extremes of refractive error.
2. Glaucoma suspects
3. Any media opacities like corneal opacity
4. Patients with co existing retinal pathologies
5. Non glaucomatous optic neuropathies
6. Ocular traumas
7. Systemic illness like Diabetes mellitus and Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is expected to
- establish the correlation of changes in FAZ by OCTA with deranged visual fields in open angle glaucoma patients.
|
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study is expected
- correlate and compare the findings in FAZ by OCTA and in visual fields in both the groups. |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
19/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/08/2025 |
| 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
|
Glaucoma is big challenge worldwide . Patients with early glaucoma go undetected on visual field examination. By doing this study we expect to identify the extent to which glaucoma affects the FAZ and understand its correlation with the visual field changes |