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.
Not Applicable
Completed
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitus
- Registration Number
- CTRI/2020/07/026649
- Lead Sponsor
- Carl Zeiss India Bangalore Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To collect 2 images per eye (nasal and temporal, according to UWF protocol) from each subject from CLARUS 500 <br/ ><br>2.To collect 1 OCT scans (6x6 mm macular cube scan) from CIRRUS HD - OCT Model 5000 per eye from each subject <br/ ><br>Timepoint: 1. Collect fundus image per eye using CLARUS 500 fundus camera <br/ ><br>2. Collect OCT scan per eye using CIRRUS HD - OCT Model 5000 OCT camera
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable