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Clinical Trials/NCT05527535
NCT05527535
Unknown
Not Applicable

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

Rajavithi Hospital0 sites34,500 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Rajavithi Hospital
Enrollment
34500
Primary Endpoint
Effectiveness of AI in diabetic retinopathy screening
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
September 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Effectiveness of AI in diabetic retinopathy screening

Time Frame: Throughout the whole period of screening, approximately 6 months

Referral adherance of patients in AI group in percentage

Efficiency of AI in diabetic retinopathy screening

Time Frame: Throughout the whole period of screening, approximately 6 months

Cost in development and implement of AI system in Thai baht unit

Secondary Outcomes

  • Satisfaction of patients and health care personnel in AI-based screening(At the end of the screening, approximately at Month 6)

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