| CTRI Number |
CTRI/2024/03/064518 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Diabetic Retinopathy Outcomes and Pathways |
|
Scientific Title of Study
|
Artificial Intelligence enabled referral pathways for early diagnosis of complications arising from diabetes: application to 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.Padmaja Kumari |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Banjara Hills, Road No:02
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
rpk@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Raja Narayanan |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Banjara Hills, Road No:02
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9177111975 |
| Fax |
|
| Email |
narayanan@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Raja Narayanan |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Banjara Hills,Road No:02
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9177111975 |
| Fax |
|
| Email |
narayanan@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute
Banjara Hills,Road No:02
Hyderabad 500034
Telangana
India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Banjara Hills
Hyderabad |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShyam Kalavalapalli |
Idea Clinics |
8-3-167/A/16,P-16, Laxmi Nagar, AG Colony, Hyderabad, Telangana 500045
Hyderabad
TELANGANA |
7396642302
md@ideaclinics.com |
| DrPadmaja Kumari |
L V Prasad Eye Institute |
L V Prasad Eye Institute
GPR Building,1st floor Clinical Research Department,Room No 125
Banjara Hills
Hyderabad
Hyderabad
TELANGANA |
9000151559
rpk@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
| Tanvir Hospital Institutional Ethis Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cohort |
Patients screened at the diabetes clinic using Artificial Intelligence and referred to the ophthalmology clinic as per the proposed pathway.
Follow ups 3 months , 6 months and 1 year.
|
| Comparator Agent |
Standard of care |
Patients who arrive at the ophthalmology clinic as per current practice either self walk ins or referrals from other healthcare providers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Idea clinic (physician-led)DR screening pathway
2.People with diabetis (PWD) who have never had a fundus examination or fundus photo screening
3.PWD willing to participate
|
|
| ExclusionCriteria |
| Details |
Patients with diagnosis of DR or treatment for DR |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A key outcome is the establishment of a referral pathway to coordinate the disparate parts of a private healthcare system and provide early diagnosis of chronic conditions such as DR.
|
Total duration will be 1 year.
Follow ups is 3 months, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| establishment of the accuracy of screening using AI-enabled cameras operated by non-ophthalmology technicians |
3,6 months and annually as per diabetic retinopathy diagnosis |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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="1"
Days="1" |
|
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 investigate the feasibility and cost-effectiveness of an AI-enabled systematic DR screening program at a diabetes clinic and a systematic referral pathway to a tertiary eye clinic. People with diabetes, especially those with greater risk of microvascular complications, regularly visit their diabetes specialist. Hence, we hypothesise that such an intervention could lead to earlier detection of DR and visual impairment caused by it compared to routine DR care pathways at a tertiary eye care setting, improve the overall management of DR and reduce the risk of severe vision loss. |