| CTRI Number |
CTRI/2025/08/093433 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Optimization and Validation of an Artificial Intelligence Model for Predicting Chronic Kidney Disease Using Retinal Fundus Images |
|
Scientific Title of Study
|
Building a healthier future: Artificial Intelligence-based early diagnosis of chronic kidney disease through retinal images |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smita Divyaveer |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 6 Ground Floor Department of Nephrology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Divyaveer |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 6 Ground Floor Department of Nephrology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Divyaveer |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room No 6 Ground Floor Department of Nephrology PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8208839726 |
| Fax |
|
| Email |
divyaveer.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
LifeBytes India Private Limited |
| Address |
1519/10,9th main, Shakara Nagar, Banglore 560092 |
| Type of Sponsor |
Other [Bioinformatics consulting firm] |
|
|
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 Smita Divyaveer |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Room No 6 Ground Floor Department of Nephrology.
Chandigarh
CHANDIGARH |
08208839726
divyaveer.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with CKD (all stages), diabetes, or hypertension presenting at PGIMER, Chandigarh, will be recruited to identify retinal markers for early CKD diagnosis. |
|
| ExclusionCriteria |
| Details |
Patients with a history of eye injury or prior eye surgery will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum creatinine and proteinuria |
baseline and three monthly till 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="3384"
Sample Size from India="3384"
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)
|
01/09/2025 |
| 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="3"
Months="0"
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
|
This study aims to optimize and validate an artificial intelligence (AI)-based model for the early diagnosis of chronic kidney disease (CKD) using retinal fundus images. A total of 3384 patients with CKD or diabetes or hypertension and control group will be enrolled at PGIMER, Chandigarh. Retinal images, clinical data, and blood/urine biomarkers will be collected, with blood samples also biobanked for future research. Data will be anonymized and analyzed by LifeBytes, Bengaluru, to develop and test the AI algorithm. The goal is to create a non-invasive, cost-effective, and scalable screening tool for early CKD detection, particularly suited for low-resource healthcare settings. |