None listed
Conditions
Interventions
Control Intervention1: VISUHEALTH® (Remote Retina Wellness Solution for Blindness Prevention): Diabetic Retinopathy (DR) Screening by reference standard means the following tests were performed
Visual acuity test, slit lamp biomicroscopy, In-Direct (dilated) fundoscopy and Interpretation by the Investigator.
DR Screening by remote image reading means undilated retinal fundus photography by
Sponsors
Carl Zeiss India Pvt Ltd
Eligibility
Inclusion 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 4. Subjects with a level of understanding and willingness to fully comply with study procedures scheduled by the study site
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr T C Ganesh Babu
Carl Zeiss India
Outcome results
None listed