| CTRI Number |
CTRI/2018/01/011065 [Registered on: 01/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Data Collection |
| Study Design |
Other |
|
Public Title of Study
|
Assisted read study for identifying diabetic eye diseases using an automated detection algorithm |
|
Scientific Title of Study
|
ARDA (Automated Detection Algorithm) assisted read study protocol - Aravind Diabetic Retinopathy Evaluation Software (ADRES) related study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Kim |
| Designation |
Chief Medical Officer |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Retina Vitreous Clinic
Room No. 200
2nd Floor, OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356102 |
| Fax |
04522530984 |
| Email |
kim@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Gulshan |
| Designation |
Research Scientist |
| Affiliation |
Google Inc |
| Address |
Google research department,
Google India Pvt Ltd Tower E,
RMZ Infinity Old Madras Road
Bangalore
KARNATAKA
560016
India |
| Phone |
919818043473 |
| Fax |
918067218100 |
| Email |
varungulshan@google.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Gulshan |
| Designation |
Research Scientist |
| Affiliation |
Google Inc |
| Address |
Google research department,
Google India Pvt Ltd Tower E,
RMZ Infinity Old Madras Road
Bangalore
KARNATAKA
560016
India |
| Phone |
919818043473 |
| Fax |
918067218100 |
| Email |
varungulshan@google.com |
|
|
Source of Monetary or Material Support
|
| Google Inc
1600 Amphitheatre Pkwy Mountain View, CA, USA |
|
|
Primary Sponsor
|
| Name |
Google Inc |
| Address |
1600 Amphitheatre Pkwy Mountain View, CA, USA |
| Type of Sponsor |
Other [Corporate] |
|
|
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 R Kim |
Aravind Eye Hospital and PG Institute of Ophthalmology |
Retina and Vitreous Department,
Room No: 200, 2nd Floor, OPD Block, No.1 Anna Nagar
Madurai
TAMIL NADU |
04524356102
04522530984
kim@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Recruitment of patients from the diabetic clinics which use ADRES (Aravind Diabetic Retinopathy Evaluation Software) grading system. An eligible patient must have a diagnosis of diabetes mellitus.
|
|
| ExclusionCriteria |
| Details |
Non-diabetic patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This programme could be used to screen for diabetic eye disease in peripheral diabetic centres |
4-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The sensitivity and specificity of the software in detecting severe or worse diabetic retinopathy and referrable diabetic macular edema as compared to trained human graders. |
4-6 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1000"
Final Enrollment numbers achieved (India)="1000" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/12/2017 |
| Date of Study Completion (India) |
24/07/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
purpose is the clinical validation of the ARDA software, which automates the
detection of diabetic retinopathy from retinal fundus images.
|
|