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Clinical validation of DR AI software

Clinical Validation of an Autonomous Online AI-based diagnostic system for the Detection of Diabetic Retinopathy - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106486
Enrollment
281
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: NIL: NIL

Sponsors

Oivi Tech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Before enrollment, a documented diagnosis of diabetes mellitus, e.g.: a) Documented diagnosis of Haemoglobin A1c (HbA1c) more than or equal to 6.5 percentage within 3 months of study initiation OR b) Fasting Plasma Glucose (FPG) more than or equal to 126 mg per dL (7.0 mmol per L) within 10 days of study initiation 2) Age 18 or older 3) Understand the study and volunteer to sign the informed consent

Exclusion criteria

Exclusion criteria: 1) Diagnosed with radiation retinopathy or retinal vein occlusion. 2) Floaters 3) Participant is hypersensitive to light 4) Participant recently underwent photodynamic therapy 5) Participant is taking medication that causes photosensitivity

Design outcomes

Primary

MeasureTime frame
Measure of sensitivity and specificity for mtmDR against reference standardsTimepoint: Baseline—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactKhaleel Udyawar

Oivi Tech

aparna@oivi.co9966619702

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026