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Computer Detection of Diabetic Retinopathy compared to screening model by remote image reading

A clinical study to validate the performance of diabetic retinopathy screening algorithm (SIKKIM 1.0) in detecting diabetic retinopathy by processing undilated retinal fundus photographs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009128
Enrollment
5000
Registered
2017-07-27
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: null- Subjects with known history of Diabetic mellitus

Interventions

Intervention1: SIKKIM 1.0: SIKKIM 1.0 is automated screening web-service with an optimization algorithm using the machine learning teachnique of deep neural networks (DNNs) to categorize non-mydriatic

Sponsors

Carl Zeiss India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Single field undilated retinal fundus photographs acquired using VISUSCOUT 100 fundus camera 2. A 40º field of view retinal fundus photograph with macula positioned in the center and optic nerve head visible 3. The retinal fundus photograph meeting image quality

Exclusion criteria

Exclusion criteria: 1. The retinal fundus photographs not been evaluated for meeting image quality 2. The retinal fundus photographs not meeting image quality. The retinal fundus photographs acquired from non-diabetic subjects 3. The retinal fundus photographs acquired from non-diabetic subjects

Design outcomes

Primary

MeasureTime frame
1. Assess the effectiveness of SIKKIM 1.0 in diabetic retinopathy (DR) screening Timepoint: [Time Frame 1 Month]—

Secondary

MeasureTime frame
1. Compare between SIKKIM 1.0 grading and reference standard for undilated retinal fundus photographsTimepoint: [Time Frame 1 Month]—

Countries

India

Contacts

Public ContactMr Ravi Rajhans

Carl Zeiss India

ganesh.babu@zeiss.com080-43438124

Outcome results

None listed

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