Computer Automated Detection (CAD) programme in identifying the presence of diabetic retinopathy (DR) and diabetic macular edema (DME) in persons with diabetes
Phase 4
Completed
- Conditions
- Health Condition 1: H350- Background retinopathy and retinalvascular changesHealth Condition 2: null- Diabetes Mellitus
- Registration Number
- CTRI/2017/11/010588
- Lead Sponsor
- Google Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
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.
Exclusion Criteria
Non-diabetic patients and other than the above said eligibility criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 4-6 months
- Secondary Outcome Measures
Name Time Method 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.Timepoint: 4-6 months