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A clinical study to compare effectiveness of screening of retinal conditions of an eye by a software in detecting retinal diseases (diseases related to back of your eye) by processing undilated (without dilating the eyes) retinal fundus (interior surface of the eye) photographs.

A clinical study to evaluate the performance of automated screening algorithm (SIKKIM 500) for detection of retinal conditions referable to ophthalmologist by processing non-mydriatic retinal fundus photographs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018420
Enrollment
5500
Registered
2019-04-04
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

None listed

Interventions

Intervention1: SIKKIM 500: SIKKIM 500 is an automated screening web service with an optimization algorithm using the machine learning technique of deep neural networks (DNNs) to categorize non-mydriat

Sponsors

Carl Zeiss India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Single, 40 degree, non-mydriatic, central field, macula centered, optic nerve head visible retinal fundus photographs acquired using VISUSCOUT 100 fundus camera 2. Retinal fundus photographs obtained from 18 years and older (Adult, Older Adult) population of either gender 3. Retinal fundus photograph meeting image quality criteria

Exclusion criteria

Exclusion criteria: 1. Retinal fundus photographs not been evaluated for image quality criteria 2. Retinal fundus photographs not meeting image quality criteria 3. Retinal fundus photographs acquired from <18 years age group

Design outcomes

Primary

MeasureTime frame
To determine the sensitivity of detecting retinal conditions for referral to ophthalmologist on an eye-specific basisTimepoint: 4 Months—

Secondary

MeasureTime frame
To determine the specificity of detecting retinal conditions for referral to ophthalmologist on an eye-specific basisTimepoint: 4 Months—

Countries

India

Contacts

Public ContactRavi Rajhans

Carl Zeiss India

ganesh.babu@zeiss.com080-43438124

Outcome results

None listed

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