Evaluation of VeriSee AI-Assisted Diagnostic Software for Screening Age-Related Macular Degeneration and Diabetic Retinopathy

What this Trial Is About

Researchers are evaluating the effectiveness and cost-effectiveness of an artificial intelligence AI-assisted diagnostic software called VeriSee in screening for common eye diseases, specifically age-related macular degeneration AMD and diabetic retinopathy DR. The study aims to provide scientific evidence on how this AI system can support ophthalmologists in diagnosing these conditions more efficiently and improve ophthalmic disease diagnosis and treatment. This effort addresses challenges like low patient attendance and uneven distribution of diagnostic resources in current clinical practice. Participants will undergo fundus photography screening using VeriSee AI-assisted diagnostic software, which analyzes color fundus images to assess disease presence and image quality. Ophthalmologists will also independently interpret the same images, and the results from the AI system will be compared with the physicians diagnoses. This study focuses on the diagnostic performance of VeriSee for AMD and DR in non-retinal subspecialty clinics, with different age criteria for each condition. During the study, participants fundus images will be collected and analyzed using the AI system, while clinical history data will also be gathered when the VeriSee system is not used. The study will measure sensitivity, specificity, and concordance between AI screening and physician-confirmed diagnoses within about one month. Additionally, total cost analysis including direct and indirect costs will be evaluated over a 12-month period after screening. Participant involvement includes undergoing screening and data collection for up to one year to assess clinical and economic outcomes.

Effectiveness and Cost-Effectiveness Evaluations of AI-Assisted Diagnostic Software (VeriSee) for Ophthalmic Disease Screening