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Collection of eye data from diabetic patients who were imaged on PLEX Elite Optical Coherence Tomography device for diabetic retinopathy evaluation

A clinical study to collect Optical Coherence Tomography (OCT) Angiography data from patients with a confirmed diagnosis of diabetes who are being scanned on the ZEISS PLEX Elite 9000 OCT Angiography device for diabetic retinopathy assessment. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/08/072812
Enrollment
200
Registered
2024-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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 Health Condition 2: H578- Other specified disorders of eye and adnexa Health Condition 3: E113- Type 2 diabetes mellitus with ophthalmic complications

Interventions

Control Intervention1: NIL: NIL

Sponsors

Carl Zeiss India Bangalore Private Limited.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 years and above with confirmed diagnosis of Type 1 and Type 2 Diabetes 2. Patients who consent to share their data for research and development purposes. 3. Patients with the following stages of DR and the respective distribution: 3.1 No DR (15%) 3.2 Mild NPDR (25%) 3.3 Moderate NPDR (25%) 3.4 Severe NPDR (25%) 3.5 Proliferative DR (10%) 3.6 Within the dataset of various DR stages, a small subset of the data shall fulfil the following criterion: 3.6.1 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 (in last 6 months from date of acquisition) of retinal artery or vein occlusion.

Design outcomes

Primary

MeasureTime frame
The prospective study aims to gather OCTA image data and clinical information from 200 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: Time points are not applicable in this study as this is a data collection study only. The patients with confirmed diagnosis of diabetic retinopathy shall be enrolled in this study.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactGANESH BABU TC

Carl Zeiss India (Bangalore) Private Limited

ganesh.babu@zeiss.com8043438124

Outcome results

None listed

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