| CTRI Number |
CTRI/2020/03/024000 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
06/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the Artificial Intelligence Software in detection of Diabetic Retinopathy |
|
Scientific Title of Study
|
Comparison of Staging of Diabetic Retinopathy by an Offline Artificial Intelligence with onsite doctor examination and Fundus Grading by retina specialist |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEH/PDY/EC/OA/71/2019 version 01 03/01/2020 |
Protocol Number |
| REF/2020/02/031592 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sivaranjani |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 22, Vitreoretina Services, Aravind Eye Hospital,Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
drsivaranjani.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sivaranjani |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 22, Vitreoretina Services, Aravind Eye Hospital,Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
drsivaranjani.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sivaranjani |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 22, Vitreoretina Services, Aravind Eye Hospital,Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
drsivaranjani.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Remidio Fundus Camera provided by Remidio |
|
|
Primary Sponsor
|
| Name |
Dr S Sivaranjani |
| Address |
No22 Vitreoretina Services Aravind Eye Hospital Thavalakuppam Pondicherry. |
| Type of Sponsor |
Other [Self] |
|
|
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 S Sivaranjani |
Aravind Eye Hospital Pondicherry |
Cuddalore Main Road Thavalakuppam Pondicherry
Pondicherry
PONDICHERRY |
9943759150
drsivaranjani.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital Pondicherry |
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 |
Artificial Intelligence |
Grading by Artificial Intelligence |
| Comparator Agent |
Onsite doctor |
Grading by Artificial Intelligence will be compared to grading by the onsite doctor in camp |
| Comparator Agent |
Retina Specialist |
Grading by Artificial Intelligence will be compared to grading by Retina Specialist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the diabetic patients visiting the DR screening camps with pupil size 3 mm or more, cataract with grade senile immature cataract with nuclear sclerosis II (NSII) and with clear cornea. |
|
| ExclusionCriteria |
| Details |
Patients with macular or leucomatous corneal opacity, cataract with grade more than senile immature cataract with nuclear sclerosis II. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the accuracy of grading done by Artificial Intelligence |
Once the recruitment is completed, the images will be sent to Retina Specialist and assessed. Time point will be 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the number of patients with Diabetic Retinopathy in patients who come for a Diabetic Retinopathy camp. |
By the end of recruitment - 3 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
20/03/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: The purpose of the study is to simplify the screening of Diabetic Retinopathy and to create public awareness. Artificial intelligence can play a unique role in public health screening
for detection of diabetic Retinopathy. Evaluation of fundus
photos through an offline DR Grading software may be an effective tool in a
screening setting to determine critical levels of diabetic retinopathy for
prompt specialist referral. Findings: There are no findings yet. |