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

Primary Purpose

Diabetic Retinopathy, Artificial Intelligence, Screening

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Artificial Intelligence
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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)

Sites / Locations

  • Rajavithi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

AI workflow

Manual workflow

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

User trust and acceptability
Assessment of staff satisfaction with workflows and patient experience in each arm
Screening throughput
Assess the number of patients who successfully completed screening in a given day in the AI versus manual arm
Assess AI performance
Confirm sensitivity and specificity of AI reading as demonstrated in previous prospective study (THAIGER, TCTR20190902002)

Full Information

First Posted
December 8, 2021
Last Updated
August 31, 2022
Sponsor
Rajavithi Hospital
Collaborators
Health Systems Research Institute, Google LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT05166122
Brief Title
Implementation of an Integrated System of Artificial Intelligence and Referral Tracking for Real-time Diabetic Retinopathy Screening
Official Title
Implementation of an Integrated System of Artificial Intelligence and Referral Tracking for Real-time Diabetic Retinopathy Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
Collaborators
Health Systems Research Institute, Google LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Artificial Intelligence, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AI workflow
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual workflow
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Artificial Intelligence
Intervention Description
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
Primary Outcome Measure Information:
Title
Referral adherence
Description
Total number of patients who completed referral visit in each arm (ie, presented to tertiary eye care center)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
User trust and acceptability
Description
Assessment of staff satisfaction with workflows and patient experience in each arm
Time Frame
6 months
Title
Screening throughput
Description
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
Title
Assess AI performance
Description
Confirm sensitivity and specificity of AI reading as demonstrated in previous prospective study (THAIGER, TCTR20190902002)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paisan Ruamviboonsuk, MD
Phone
081-489-4455
Email
paisan.trs@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anyarak Amornpetchsathaporn, MD
Phone
083-167-7170
Email
yinyin.anyarak@gmail.com
Facility Information:
Facility Name
Rajavithi hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajavithi hospital
Phone
0661155598
Email
paisan.trs@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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