Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

NCT ID: NCT05527535

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

34500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AI screening group

Diabetes mellitus patients undergo diabetic retinopathy screening by AI

Diabetic retinopathy screening by artificial intelligence

Intervention Type DIAGNOSTIC_TEST

Screening diabetic patients' eyes with AI through digital health platform

Manual screening group

Diabetes mellitus patients undergo diabetic retinopathy screening by health care personnel

Diabetic retinopathy screening by healthcare personnel

Intervention Type DIAGNOSTIC_TEST

Screening diabetic patients' eyes by conventional method (healthcare personnel)

Interventions

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Diabetic retinopathy screening by artificial intelligence

Screening diabetic patients' eyes with AI through digital health platform

Intervention Type DIAGNOSTIC_TEST

Diabetic retinopathy screening by healthcare personnel

Screening diabetic patients' eyes by conventional method (healthcare personnel)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Systems Research Institute,Thailand

OTHER_GOV

Sponsor Role collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Paisan Ruamviboonsuk, Dr.

Role: CONTACT

+6622062900 ext. 30731

Methaphon Chainakul, Dr.

Role: CONTACT

+6622062900 ext. 30731

Other Identifiers

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65057

Identifier Type: -

Identifier Source: org_study_id

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