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A clinical study to collect the retinal images (fundus photographs and Optical coherence tomography(OCT) scans) with different severity level of diabetic retinopathy disease from CLARUS 500 fundus Camera and CIRRUS HD - OCT MODEL 5000 imaging devices.

A clinical study to collect the different severity levels of diabetic retinopathy fundus photographs from CLARUS 500 and OCT scan from CIRRUS HD - OCT MODEL 5000

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026649
Enrollment
100
Registered
2020-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E08-E13- Diabetes mellitus

Interventions

None listed

Sponsors

Carl Zeiss India Bangalore Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 1 or type 2 diabetes mellitus and any severity of DR, pre-diabetes does not qualify (Diabetes with No DR, Mild NPDR, Moderate NPDR, Severe NPDR, Proliferative DR)

Exclusion criteria

Exclusion criteria: 1.Significant media opacity precluding adequate imaging of the retina 2.Concurrent retinal disease that could confound DR severity grading, except hypertensive retinopathy or a finding of Hollenhorst plaque 3.History of pan-retinal photocoagulation for PDR and focal/grid laser for DME

Design outcomes

Primary

MeasureTime frame
1.To collect 2 images per eye (nasal and temporal, according to UWF protocol) from each subject from CLARUS 500 2.To collect 1 OCT scans (6x6 mm macular cube scan) from CIRRUS HD - OCT Model 5000 per eye from each subject Timepoint: 1. Collect fundus image per eye using CLARUS 500 fundus camera 2. Collect OCT scan per eye using CIRRUS HD - OCT Model 5000 OCT camera—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Ganesh Babu

Carl Zeiss India (Bangalore) Pvt Ltd

ganesh.babu@zeiss.com9880225622

Outcome results

None listed

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