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Status unknownNCT05166122Updated Sep 2, 2022

Implementation of an Integrated System of Artificial Intelligence and Referral Tracking for Real-time Diabetic Retinopathy Screening

An interventional study of Artificial Intelligence in Diabetic Retinopathy, Artificial Intelligence and Screening, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Status unknown at 1 site in Thailand. 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 · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research study aims to bring an artificial intelligence system to screen for diabetic retinopathy (DR) along with referral tracking systems to the screening unit in Uthai Hospital in Phra Nakhon Sri Ayutthaya to assess the effectiveness of screening and follow-up of patients referred to Phra Nakhon Sri Ayutthaya Hospital. It will be compared with the existing screening system and follow up with regular referral by personnel

Read the detailed description

Diabetic retinopathy is the most common ocular complication in people with diabetes. It is a leading cause of vision loss and blindness in people aged 20-64 years around the world because in the early stages of the disease there is no warning, causing the patients to be unaware. If the blood sugar content is allowed to increase, severe diabetic retinopathy can occur leading to blindness.

The incidence of diabetic retinopathy in diabetic patients tends to increase with the duration of diabetes. And according to the age of the patient, it was found that within 20 years, patients with diabetes type 1 with diabetic retinopathy is about 99% and diabetes type 2 with diabetic retinopathy is about 60%.

Screening for diabetic retinopathy is accepted and performed in health systems around the world. Evidence shows that screening can reduce blindness(1-3). Thailand uses the percentage of diabetic patients who have been eye tested. It is one of the indicators of service quality of the Eye Health District of the Ministry of Public Health. Screening for diabetic retinopathy using the retinal imaging method is cost-effective. It provides diabetic patients in distant places access to screening, such as bringing a mobile retina camera to take pictures in the community in conjunction with the use of teleophthalmology technology in screening(4-6). But according to a report by the Ministry of Public Health in the HDC system in 2015-2017, it was found that only 40% of the patients who were screened for diabetic retinopathy had not reached the 60% target.

In 2016, Rajavithi Hospital, in collaboration with researchers in Google Health, assessed the use of artificial intelligence to read retina images of diabetic patients in all 13 health districts of Thailand. It found that the artificial intelligence system was able to identify patients for referral to ophthalmologists (moderate non-proliferative diabetic retinopathy [NPDR]) with 95% sensitivity and 96% specificity, which is 73% higher than screening personnel specificity 98%.

From thereon, a prospective study with the introduction of artificial intelligence system was conducted to screen real patients in the project titled "Thailand-Google Prospective, Real-World Deployment of Artificial Intelligence for Diabetic Retinopathy Screening" (THAIGER) (NCT TCTR 20190902002) in 2018 to 2020 to assess the feasibility, including obstacles to implementing an intelligence-based screening process. The project integrated AI into the nation-wide screening system of the country. By conducting research in the primary care facilities, Rajavithi Hospital and 9 community hospitals in Pathum Thani Province and Chiang Mai, the diabetic patients in the THAIGER project received the results of reading images by artificial intelligence in real time. However, it was found that of the patients who were referred, very few actually went to see a doctor. There are also images that were unreadable (ungradable) by the artificial intelligence. And the artificial intelligence used in THAIGER has not yet been fully integrated into the screening system, including with a patient tracking system.

This research study aims to bring an artificial intelligence system to screen for diabetic retinopathy (DR) along with referral tracking systems to the screening unit in Uthai Hospital in Phra Nakhon Sri Ayutthaya to assess the effectiveness of screening and follow-up of patients referred to Phra Nakhon Sri Ayutthaya Hospital. It will be compared with the existing screening system and follow up with regular referral by personnel.

02

Conditions studied

  • Diabetic Retinopathy
  • Artificial Intelligence
  • Screening
03

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 1,600 is above the median of 60 across 500 interventional 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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 18 years and over.
  • Patients who have been screened for diabetic retinopathy at Uthai Hospital Phra Nakhon Sri Ayutthaya Province that can refer patients to Phra Nakhon Sri Ayutthaya Hospital to see an ophthalmologist
  • People with diabetes who are listed on the civil registry
  • Able to take pictures of the retina at least 1 eye.

Exclusion criteria

Exclusion Criteria:

  • Being a patient in a community hospital with an in-house ophthalmologist
  • Patients who were previously diagnosed for the following conditions / diseases: retinal edema, diabetic retinopathy (NPDR, PDR). The retina is affected by radiation (Radiation retinopathy) or retinal vein blockage (RVO).
  • Past history of laser retinal treatment or retinal surgery
  • Having other eye diseases (non-diabetic retinopathy) that requires referral to an ophthalmologist.
  • Inability to take pictures of the retina (for any reason)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,600 participants (estimated)

Study arms

  • Active comparator
    AI workflow

    In AI work flow, patients will be screened by taking normal retinal images and all images will be assessed for the severity of diabetic retinopathy by a computerized artificial intelligence system immediately after the photograph is taken via the Internet and retinal images will be sent to the retinal ophthalmologist for overreading.

    Diagnostic Test: Artificial Intelligence

  • No intervention
    Manual workflow

    Volunteers who have been screened by manual workflow will be screened by imaging the retina and image that are not normal will be sent to assess the severity of diabetic retinopathy by specialist staff.

Interventions

  • Diagnostic testArtificial Intelligence

    Introduction of digitized system with an AI tool to detect and intrepret the severity of diabetic retinopathy and presence of diabetic macular edema in screening for diabetes patients

06

What researchers measure

Primary outcomes

  1. Referral adherence

    Total number of patients who completed referral visit in each arm (ie, presented to tertiary eye care center)

    Time frame: 6 months

Secondary outcomes

  1. User trust and acceptability

    Assessment of staff satisfaction with workflows and patient experience in each arm

    Time frame: 6 months

  2. Screening throughput

    Assess the number of patients who successfully completed screening in a given day in the AI versus manual arm

    Time frame: Compare time unit of 1 day for each arm

  3. Assess AI performance

    Confirm sensitivity and specificity of AI reading as demonstrated in previous prospective study (THAIGER, TCTR20190902002)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Rajavithi hospital
    Bangkok, 10400, Thailand
    Recruiting
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References and documents

Individual participant data

Plan to share: No

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
NCT05166122
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Collaborators
Health Systems Research Institute, Google LLC.
Responsible party
Sponsor
First posted
Dec 21, 2021
Start date
Jan 1, 2022
Primary completion
Aug 19, 2022
Completion
Sep 30, 2022 (estimated)
Last update
Sep 2, 2022

Study contacts

Paisan Ruamviboonsuk, MD
Contact
paisan.trs@gmail.com
081-489-4455
Anyarak Amornpetchsathaporn, MD
Contact
yinyin.anyarak@gmail.com
083-167-7170

Oversight

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

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