Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

Rajavithi Hospital

Status: Not yet enrolling

Conditions: Diabetic Retinopathy

Treatments: Diagnostic Test: Diabetic retinopathy screening by healthcare personnel; Diagnostic Test: Diabetic retinopathy screening by artificial intelligence

Study type: Observational

Funder types: Other

Identifiers

NCT05527535

65057

Details and patient eligibility

About

Efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (AI) are limited. Investigators will implement AI for diabetic retinopathy screening in 13 health districts in Thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research.

Enrollment: 34,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record
2. No full-time ophthalmologists in those primary hospital
3. Age more than or equal to 18 years
4. Eligible for fundus photo imaging at least 1 eye

Exclusion criteria

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists
2. Patients who previously diagnosed with other causes of macular edema, for example, Age-related Macular Degeneration, Radiation Retinopathy, Retinal Vein Occlusion etc.
3. History of retinal laser or surgery
4. Other ocular diseases that require referral to ophthalmologists
5. Not eligible for fundus photo imaging for both eyes (any causes)

Trial design

34,500 participants in 2 patient groups

AI screening group

Description:

Diabetes mellitus patients undergo diabetic retinopathy screening by AI

Treatment:

Diagnostic Test: Diabetic retinopathy screening by artificial intelligence

Manual screening group

Description:

Diabetes mellitus patients undergo diabetic retinopathy screening by health care personnel

Treatment:

Diagnostic Test: Diabetic retinopathy screening by healthcare personnel