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Understand the quality of the Oivi camera for detecting the Diabetic Retinopathy comparing with Zeiss camera

Validation of Oivi camera for detecting referrable DR against IDO and Zeiss Visuscout 100 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076885
Enrollment
230
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: H348- Other retinal vascular occlusions

Interventions

Control Intervention1: NIL: NIL

Sponsors

Oivi Tech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age above 18 years 2 Patients previously diagnosed with referable non proliferative 3. Diabetic Retinopathy within 6 months of the study date 4 Pupil size above 4mm 5 Who proves consent capture the retinal images

Exclusion criteria

Exclusion criteria: 1 Age less than18 years 2 Pupil size less 4mm 3 Pregnant women 4 With media opacity, photosensitive, sensitive to eye drops 5 Significant cataracts

Design outcomes

Primary

MeasureTime frame
To establish the sensitivity and specificity of Oivi in detecting referrable DR and clinically significant DME in comparison to IDO 2. To establish the agreement for referrable DR between Oivi and Zeiss Visuscout 100 fundus camerasTimepoint: 3 Months—

Secondary

MeasureTime frame
To correlate the referrable DR and DME lesions observed on Falcon retinal image to that of clinical examination, IDO and Zeiss Visuscout 100 fundus cameras 2. To establish inter-observer agreement for lesion detection on Oivi fundus imageTimepoint: 4 Months—

Countries

India

Contacts

Public ContactDrMERIN DICKSON MICKHAYEL

Amrita institute of medical science

gopalspillai@gmail.com9447391266

Outcome results

None listed

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