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Collection of Eye Scan Images from Diabetic Patients Using the ZEISS PLEX Elite 9000 device.

Clinical Study For Retrospective Collection Of Optical Coherence Tomography (Oct) Angiography Data From 300 Unique Patients With A Confirmed Diagnosis Of Diabetes Who Have Undergone Scanning Using The Zeiss Plex Elite 9000 Oct Angiography Device For The Assessment Of Diabetic Retinopathy. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/113073
Enrollment
300
Registered
2026-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Carl Zeiss India Bangalore Private Limited.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Type 1 or Type 2 Diabetes. 2. Patients who had consented to share their data for research and development purposes. 3. Patient data with the following stages of diabetic retinopathy (DR), with the respective distribution in the dataset: - Mild NPDR (10%) - Moderate NPDR (20%) - Severe NPDR (50%) - Proliferative DR (20%) 4. Within the dataset, a small subset of the data should also meet the following criterion: - Presence of Diabetic Macular Edema (DME) (5%)

Exclusion criteria

Exclusion criteria: 1. Patients who have not consented to share their data for research and development purposes. 2. Known history, within 6 months prior to the data of image acquisition, of retinal artery or retinal vein occlusion.

Design outcomes

Primary

MeasureTime frame
The retrospective study aims to collect OCTA image data and clinical information from 300 diabetic patients using the ZEISS PLEX Elite 9000 OCT Angiography device. The outcome of this study is data collection for research and development purposes.Timepoint: The primary time point for data collection will be the baseline visit, defined as the first visit when the OCTA scan was performed using the ZEISS PLEX Elite 9000 OCTA Angiography device.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactMansi Gupta

Carl Zeiss India (Bangalore) Private Limited

ganesh.babu@zeiss.com9880225622

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026