A clinical study to compare effectiveness of remote screening model with standard screening method for Diabetic Retinopathyâ??
- Conditions
- Health Condition 1: null- Subjects with known history of diabetes mellitus
- Registration Number
- CTRI/2017/06/008832
- Lead Sponsor
- Carl Zeiss India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 238
All subjects (either eye OD/OS) must fulfil all of the following criteria
1. Male or female subjects, 18 years of age or older with known history of diabetes mellitus
2. Subjects with or without known diagnosis of DR of any grade
3. Subject with cataract grade <= N02 based on slit lamp examination
4. Subjects with a level of understanding and willingness to fully comply with study procedures scheduled by the study site
1. History of angle closure glaucoma in either eye
2. Presence of extensive cataract (>= grade N03) in the designated eye for fundus photography
3. Unable to understand and follow the instructions on study procedures
4. Unfit for undergoing study procedures in view of the Investigator
5. Any active infection of anterior or posterior segments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the effectiveness of DR screening model by remote image reading in detecting DR and sight threatening DR changes during screening processTimepoint: Not applicable
- Secondary Outcome Measures
Name Time Method Comparison between DR screening by reference standard and DR screening model by remote image reading for level of agreement in interpretation of the diabetic retinopathy findings during screeningTimepoint: Not applicable