Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study

Medios Technologies

Status: Unknown

Conditions: Diabetic Retinopathy

Treatments: Other: diabetic retinopathy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03572699

SMART1

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.