| CTRI Number |
CTRI/2024/04/065066 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying for presence of Glaucoma in Different Stages of Diabetic Eye Disease: A research study. |
|
Scientific Title of Study
|
Evaluation for Glaucoma in Mild, Moderate and Severe Non-Proliferative Diabetic Retinopathy - A Prospective Observational Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Kak |
| Designation |
Primary DNB Resident |
| Affiliation |
Centre for sight eye institute |
| Address |
Centre For Sight Eye Institute, Plot No 9 Sector 9 Dwarka, Delhi
Centre For Sight Eye Institute, Plot No 9 Sector 9 Dwarka, Delhi
South West
DELHI
110077
India |
| Phone |
9996681257 |
| Fax |
|
| Email |
kak.ishita18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Gen Dr Sagarika Patyal |
| Designation |
Head of Department of Ophthalmology |
| Affiliation |
Centre for sight eye institute |
| Address |
Centre for sight eye institute plot no 9 sector 9 dwarka delhi
South West
DELHI
110077
India |
| Phone |
9643437024 |
| Fax |
|
| Email |
sagarikapatyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Gen Dr Sagarika Patyal |
| Designation |
Head of Department of Ophthalmology |
| Affiliation |
Centre for sight eye institute |
| Address |
Centre for sight eye institute plot no 9 sector 9 dwarka delhi
South West
DELHI
110077
India |
| Phone |
9643437024 |
| Fax |
|
| Email |
sagarikapatyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre For Sight Eye Institute Dwarka |
|
Primary Sponsor
Modification(s)
|
| Name |
Ishita kak |
| Address |
Centre for sight eye hospital Dwarka new delhi |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for sight eye institute Dwarka |
Centre for sight eye institute plot no 9 sector 9 dwarka delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maj Gen Dr Sagarika Patyal |
Centre For Sight Eye Institute |
Room No Diagnostic 3, 2nd floor, Department of Ophthalmology
South West
DELHI |
9643437024
sagarikapatyal@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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Mild moderate severe NPDR with or without macular edema with vision greater than 6 by 24 , post intravitreal injections, post focal laser , none treatment |
|
| ExclusionCriteria |
| Details |
Advanced glaucoma Co-existing macular ischemia Co-existing juxtafoveal telangiectasia Proliferative Diabetic Retinopathy Retinal Dystrophy and Degeneration Optic atrophy Post Vitero-Retina surgeries Associated CRAO BRAO BRVO CRVO Past History of uveitis diabetic papillopathy papilloedema History of Trauma Cataract PCO Myopia Amblyopia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the Incidence of Glaucoma in mild, moderate and severe Non Proliferative Diabetic Retinopathy |
At the end of 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity & specificity of various standard diagnostic tests viz a viz optic nerve head findings Pachymetry Automated Visual Field Tesing & OCT Retinal Nerve Fiber Layer Ganglion Cell Complex for Glaucoma diagnosis in NPDR patients |
At the end of 26 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/04/2024 |
| 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 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
|
According to a study Diabetic Retinopathy might be associated with Glaucoma however certain studies do not agree with this association leading to ongoing discussions and research on this matter hence this study will contribute to understanding the coexistence of Non Proliferative Diabetic Retinopathy and Glaucoma by providing valuable insights into the incidence and diagnostic accuracy thus aiding in early diagnosis and timely treatment of patients |