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

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03572699
• Lead Sponsor: Medios Technologies Pte. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Study Start: 2018-07-11
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Diacon Hospital; 🇮🇳 Bangalore, India