Health Condition 1: null- Patient suffering from diabetes mellitus type 1 or type 2 at least for 5 years from time of screening
Conditions
Interventions
None listed
Sponsors
Bosch India
Think i Unit of Tenet Health Edutech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ready to sign informed consent form 2. Patients with age of 18 years and above 3. Patient suffering from diabetes mellitus type 1 or type 2 at least for 5 years from time of screening 4. Both male and female patients can be enrolled
Exclusion criteria
Exclusion criteria: 1. Subjects with unknown history of diabetes mellitus 2. Subjects with known history of DR 3. Potential subject cannot understand study or informed consent 4. A history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc 5. Other than cataract surgery, history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease 6. Extreme small pupil for image capturing 7. A media opacity in either eye that is severe enough to preclude good retinal photography 8. Subjects with conjunctivitis, red eye or any other inflammatory condition with photophobia. 9. Subjects with gestational DM. 10. If only unilateral retinal image is available. 11. Exclusion of media hazy eyes if found during the clinical examination (by slit lamp or standard of care)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity of detecting moderate diabetic retinopathy or more severe DR and/or significant macular edema on a person-specific basisTimepoint: Day 1- Evaluation of Fundus photographs by Software and P.I. and comparison of both the results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity (true negatives divided by true negatives plus false positives) at detecting more than moderate non proliferative diabetic retinopathy and/or significant macular edema on a person-specific basisTimepoint: Day 1 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Think i
Outcome results
None listed