CClinicalTrials.gg
Status unknownNCT05527535Updated Sep 2, 2022

Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand

An observational study in Diabetic Retinopathy, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
34,500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Diabetic Retinopathy

Keywords

  • Diabetic Retinopathy, Screening, Deep Learning Algorithm, Human Grader
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 34,500 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 36 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All diabetes mellitus patients who visit for diabetic retinopathy screening at selected primary care units and hospitals in 13 health districts in Thailand

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

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)
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
34,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • AI screening group

    Diabetes mellitus patients undergo diabetic retinopathy screening by AI

    Diagnostic Test: Diabetic retinopathy screening by artificial intelligence

  • Manual screening group

    Diabetes mellitus patients undergo diabetic retinopathy screening by health care personnel

    Diagnostic Test: Diabetic retinopathy screening by healthcare personnel

Interventions

  • Diagnostic testDiabetic retinopathy screening by artificial intelligence

    Screening diabetic patients' eyes with AI through digital health platform

  • Diagnostic testDiabetic retinopathy screening by healthcare personnel

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

06

What researchers measure

Primary outcomes

  1. Effectiveness of AI in diabetic retinopathy screening

    Referral adherance of patients in AI group in percentage

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

  2. Efficiency of AI in diabetic retinopathy screening

    Down time and failure rate of AI system

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

  3. Efficiency of AI in diabetic retinopathy screening

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

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

Secondary outcomes

  1. Satisfaction of patients and health care personnel in AI-based screening

    Measurement of health care personnel's satisfaction by well-developed questionnaire

    Time frame: At the end of the screening, approximately at Month 6

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Fear of inappropriate use of data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05527535
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Collaborators
Health Systems Research Institute (HSRI), Thailand
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Oct 3, 2022 (estimated)
Primary completion
Mar 31, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Sep 2, 2022

Study contacts

Paisan Ruamviboonsuk, Dr.
Contact
paisan.trs@gmail.com
+6622062900 ext. 30731
Methaphon Chainakul, Dr.
Contact
methaphonc1995@gmail.com
+6622062900 ext. 30731

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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