Effectiveness and Cost-Effectiveness Evaluations of AI-Assisted Diagnostic Software (VeriSee) for Ophthalmic Disease Screening
NCT ID: NCT06843499
Last Updated: 2025-06-22
Study Results
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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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-06-02
2027-12-31
Brief Summary
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Detailed Description
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However, current clinical diagnoses rely heavily on ophthalmologists, leading to challenges such as low patient attendance rates and unequal distribution of diagnostic resources. To address these issues, this study will provide robust evidence to further validate the diagnostic performance of AI-assisted screening and clinical effectiveness of the VeriSee AI-assisted diagnostic system in the detection of diabetic DR and AMD.
VeriSee AMD and VeriSee DR are AI-powered medical software tools designed to screen for AMD and DR, respectively. These systems employ advanced AI algorithms to analyze color fundus photography images, assess disease conditions, and evaluate image quality. By integrating this software into clinical workflows, physicians receive instant diagnostic support, improving efficiency and accessibility in ophthalmic disease screening.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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AI Intervention
Patients will undergo fundus photography screening using artificial intelligence-assisted diagnostic software (VeriSee). Ophthalmologists will independently interpret the same images, and the results will be compared with those generated by the AI.
The VeriSee AI-assisted diagnostic system
VeriSee AMD, VeriSee DR, and VeriSee GLC are AI-based medical software devices designed for screening age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, respectively. These systems utilize advanced AI algorithms to analyze color fundus photography images for disease assessment. By installing the software on a computer, the system can evaluate image quality, predict disease conditions, and instantly provide results to clinical physicians, serving as a diagnostic aid.
Data collection from the patient's clinical history
Data collection from the patient's clinical history was conducted because the VeriSee AI-assisted diagnostic system was not used.
Interventions
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The VeriSee AI-assisted diagnostic system
VeriSee AMD, VeriSee DR, and VeriSee GLC are AI-based medical software devices designed for screening age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, respectively. These systems utilize advanced AI algorithms to analyze color fundus photography images for disease assessment. By installing the software on a computer, the system can evaluate image quality, predict disease conditions, and instantly provide results to clinical physicians, serving as a diagnostic aid.
Data collection from the patient's clinical history
Data collection from the patient's clinical history was conducted because the VeriSee AI-assisted diagnostic system was not used.
Eligibility Criteria
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Inclusion Criteria
* VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above.
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Fu Jen Catholic University Hospital
OTHER
Min-Sheng General Hospital
OTHER
Ministry of Health and Welfare, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Countries
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Facility Contacts
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Other Identifiers
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202412086DINC
Identifier Type: -
Identifier Source: org_study_id
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