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Assisted read study for identifying diabetic eye diseases using an automated detection algorithm

ARDA (Automated Detection Algorithm) assisted read study protocol - Aravind Diabetic Retinopathy Evaluation Software (ADRES) related study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/01/011065
Enrollment
1000
Registered
2018-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

None listed

Sponsors

Google Inc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Non-diabetic patients

Design outcomes

Primary

MeasureTime frame
This programme could be used to screen for diabetic eye disease in peripheral diabetic centresTimepoint: 4-6 months

Secondary

MeasureTime frame
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.Timepoint: 4-6 months

Countries

India

Contacts

Public ContactDr Varun Gulshan

Google Inc

varungulshan@google.com919818043473

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026