Optical coherence tomography angiography data collection study in diabetic patients for assessment of diabetic retinopathy.
Not Applicable
- Conditions
- Health Condition 1: H350- Background retinopathy and retinalvascular changes
- Registration Number
- CTRI/2024/05/067797
- Lead Sponsor
- Carl Zeiss India Bangalore Private Limited.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a.Males or females 18 years of age or older
b. Patients who had consented to share their data for research & development.
c. Confirmed diagnosis of type 1 or type 2 diabetes mellitus.
d. Patients with the following stages of DR Stages and the respective distribution:
i. No DR (15%)
ii. Mild Non-Proliferative DR (20%)
iii. Moderate Non-Proliferative DR (25%)
iv. Severe Non-Proliferative DR (25%)
v. Proliferative DR (10%)
vi. Presence of Diabetic Macular Edema (5%)
Exclusion Criteria
a.Patients who had not consented to share their data for research and development
purposes.
b. Known history (in last 6 months from date of acquisition) of retinal artery or vein
occlusion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study aims to analyze OCTA data and clinical details from 200 diabetic patients using the ZEISS CIRRUS HD-OCT 5000. The outcome will provide insights into diabetic retinopathy characteristics and progression. Findings may contribute to better understanding and management of diabetic eye disease.Timepoint: Collection of Single-Visit data from Cirrus HD-OCT 5000 device.
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI