| CTRI Number |
CTRI/2024/01/061607 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Artificial Intelligence for Detecting Diabetic Changes in Eye |
|
Scientific Title of Study
|
Developing and validating an
artificial intelligence based model for 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 Pradeep Venkatesh |
| Designation |
Professor, Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 482, 4th floor,
DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES,
All India Institute of Medical Sciences (AIIMS)
ANSARI NAGAR, NEW DELHI-110029, India
7-8
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
venkyprao@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor, Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number: S3, 1st floor
DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES
All India Institute of Medical Sciences ·ANSARI NAGAR, NEW DELHI-110029, India
South
DELHI
110029
India |
| Phone |
09891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor, Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number: S3, 1st floor
DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES
All India Institute of Medical Sciences ·ANSARI NAGAR, NEW DELHI-110029, India
DELHI
110029
India |
| Phone |
09891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES,
All India Institute of Medical Sciences (AIIMS)
ANSARI NAGAR, NEW DELHI-110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Pradeep Venkatesh |
RPC |
Room number: 482, 4th floor, DR. RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES
All India Institute of Medical Sciences
ANSARI NAGAR, NEW DELHI-110029, India
South
DELHI |
01126588274
venkyprao@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS of diabetes mellitus, cooperative for fundus photography |
|
| ExclusionCriteria |
| Details |
Not giving consent, Presence of any media opacity in the eye which may degrade the quality of the fundus image, Presence of significant ptosis or lid abnormalities hampering image capture |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sensitivity, specificity, and accuracy of the AI solution in the detection and referral of diabetic retinopathy using retinal images captured from patients visiting the AIIMS eye centre. |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
30/01/2024 |
| 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="3"
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
|
Individuals with diabetes visiting the AIIMS eye centre will undergo retinal examination. Their retina images will be assessed by the artificial intelligence (AI) solution, and the resulting diagnoses will be documented. These findings will then be compared with the gold standard annotations provided by two ophthalmologists. In case of a discrepancy between the gold annotations provided by two ophthalmologists, an arbitrator will provide their independent gold annotation. |