| CTRI Number |
CTRI/2017/11/010588 [Registered on: 22/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Data Collection |
| Study Design |
Other |
|
Public Title of Study
|
Computer Automated Detection (CAD) programme in identifying the presence of diabetic retinopathy (DR) and diabetic macular edema (DME) in persons with diabetes |
|
Scientific Title of Study
|
A Study to assess the effectiveness of a Computer Automated Detection (CAD) programme in identifying the presence of diabetic retinopathy (DR) and diabetic macular edema (DME) in persons with diabetes |
| Trial Acronym |
CAD-DR |
|
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 |
Aravind Eye Hospital and PG Institute of Ophthalmology
No.1 Anna Nagar, Madurai, Tamilnadu, India
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 India Pvt Ltd
Tower E, RMZ Infinity
Old Madras Road
Bangalore
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 India Pvt Ltd
Tower E, RMZ Infinity
Old Madras Road
Bangalore
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, Roon. No. 200; 2nd Floor, OPD Block, No.1 Anna Nagar, Madurai, 625020, TamilNadu
Madurai
TAMIL NADU |
04524356102
04522530984
kim@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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, Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
An eligible patient must:(1) have a diagnosis of diabetes mellitus;
(2) have no history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed);
(3) other than cataract surgery, have no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease;
(4) have no media opacity precluding good retinal photography; and
(5) be of age 40 or older. |
|
| ExclusionCriteria |
| Details |
Non-diabetic patients and other than the above said eligibility criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The sensitivity and specificity of the software in detecting referable diabetic retinopathy and diabetic macula edema (moderate or worse DR and referable DME) as compared to trained human graders. |
4-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The sensitivity and specificity of the software in detecting severe or worse diabetic retinopathy and referable diabetic macula 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)
|
20/04/2016 |
| Date of Study Completion (India) |
20/07/2016 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in, "The Journal of the American Medical Association"
JAMA Ophthalmol. 2019;137(9):987-993. doi:10.1001/jamaophthalmol.2019.2004 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study results demonstrate that an automated algorithm identified referable
DR with performance equal to or exceeding the retinal specialists in a prospective clinical setting. |