Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

Diabetic Retinopathy Clinical Trial

Official title:

Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand: An Implementation Research

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05527535
• Other study ID #: 65057
• Status: Not yet recruiting
• Start date: October 3, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Rajavithi Hospital
• Contact: Paisan Ruamviboonsuk, Dr.
• Phone: +6622062900
• Email: paisan.trs[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34500
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Diagnostic Test:
• Diabetic retinopathy screening by artificial intelligence
Screening diabetic patients' eyes with AI through digital health platform
• Diabetic retinopathy screening by healthcare personnel
Screening diabetic patients' eyes by conventional method (healthcare personnel)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Health Systems Research Institute (HSRI), Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of AI in diabetic retinopathy screening	Referral adherance of patients in AI group in percentage	Throughout the whole period of screening, approximately 6 months
Primary	Efficiency of AI in diabetic retinopathy screening	Down time and failure rate of AI system	Throughout the whole period of screening, approximately 6 months
Primary	Efficiency of AI in diabetic retinopathy screening	Cost in development and implement of AI system in Thai baht unit	Throughout the whole period of screening, approximately 6 months
Secondary	Satisfaction of patients and health care personnel in AI-based screening	Measurement of health care personnel's satisfaction by well-developed questionnaire	At the end of the screening, approximately at Month 6