| CTRI Number |
CTRI/2025/12/098915 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Macular Microvascular Changes in Different Stages of Diabetic Retinopathy in diabetic patients Using OCTA and its reliability on disease progression. |
|
Scientific Title of Study
|
Assessment of Macular vessel density in different stages of non proliferative diabetic retinopathy |
| 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 Anju Rastogi |
| Designation |
Professor and head |
| Affiliation |
Esic medical College and hospital, faridabad |
| Address |
Room no. 04, eye opd, 2nd floor, Esic medical College and hospital, nit 3, faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9818340924 |
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Rastogi |
| Designation |
Professor and head |
| Affiliation |
Esic medical College and hospital, faridabad |
| Address |
Room no. 04, eye opd, 2nd floor, Esic medical College and hospital, nit 3, faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9818340924 |
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Rastogi |
| Designation |
Professor and head |
| Affiliation |
Esic medical College and hospital, faridabad |
| Address |
Room no. 04, eye opd, 2nd floor, Esic medical College and hospital, nit 3, faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9818340924 |
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ESIC medical College and hospital faridabad |
|
|
Primary Sponsor
|
| Name |
Esic medical College and hospital |
| Address |
Esic medical College and hospital nit 3 faridabad haryana India
Pincode -121001 |
| 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 Robin |
Esic medical College and hospital |
Room no 4
Department of ophthalmology
Faridabad
HARYANA |
9711718050
robinsingh2611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ESIC MCH FBD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of type 2 diabetes mellitus.
|
|
| ExclusionCriteria |
| Details |
Patient with proliferative diabetic retinopathy.
Presence of other retinal pathologies.
History of intraocular surgery.
Media opacity.
Glaucoma.
Intraocular inflammation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean of Macular vessel density |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Foveal avascular zone
|
1 year |
| Central macular thickness |
1 year |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/12/2025 |
| 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
|
Diabetic retinopathy is a common microvascular complication of diabetes mellitus and a leading cause of visual impairment globally. Assessment of macular vessel in different stages of non proliferative diabetic retinopathy may help in understanding disease progression and optimizing timely intervention. OCTA is a new non invesive diagnostic method used to quickly detect changes in capillary of retina and choroid. |