Diabetic Retinopathy
Conditions
Brief summary
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.
Interventions
OTHERdiabetic retinopathy
This is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI.
Sponsors
Diacon Hospital
Medios Technologies Pte. Ltd
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with type 1 or type 2 diabetes mellitus 2. Ages 18 and above 3. Male and female
Exclusion criteria
1. Persistent visual impairment in one or both eyes; 2. Subjects with corneal opacities and advanced cataract. 3. History of retinal vascular (vein or artery) occlusion; 4. Subject is contraindicated for fundus photography (for example, has light sensitivity); 5. Subject is currently enrolled in an interventional study of an investigational device or drug; 6. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater) | 3 months |
| Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater) | 3 months |
Countries
India
Contacts
Primary ContactSrikanth Y N, MS
Backup ContactBhavana Sosale, MD
Outcome results
None listed