CTRI/2017/06/008832
Completed
N/A
A prospective comparative clinical study to evaluate the effectiveness of diabetic retinopathy (DR) screening model by remote image reading and reference standard screening in detecting diabetic retinopathy
Carl Zeiss India Pvt Ltd0 sites238 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Subjects with known history of diabetes mellitus
- Sponsor
- Carl Zeiss India Pvt Ltd
- Enrollment
- 238
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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