Author(s): Martin David Harp

Key Takeaways

• The AI algorithm demonstrated strong repeatability and agreement with expert graders in segmenting hypo-reflective spaces in nAMD patients.
• The AI’s repeatability in estimating retinal hypo-reflective space volumes surpassed that of in-office imaging devices.
• The study’s success led to FDA De Novo authorization and Breakthrough Device designation for the SCANLY Home OCT device.
• The findings enhance confidence in AI-driven patient monitoring for retinal disease management.

Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in 2024.

Notal Vision has announced positive results from a pivotal study evaluating the performance of an artificial intelligence (AI) algorithm for the estimation of key biomarkers in neovascular age-related macular degeneration (nAMD) using a home-based optical coherence tomography (OCT) system. The results were recently published in Ophthalmology Science.

The cross-sectional study involved 336 nAMD patients from 6 US retina clinics presenting a diverse set of co-existing pathologic features. According to the company,¹ this makes segmenting specific biomarkers associated with nAMD particularly challenging for AI algorithms. Patients independently captured 4 images each using 2 home OCT devices while in the clinic, without any assistance from a technician. For comparison, patients were also imaged on an in-office OCT device.

In the trial, the AI algorithm looked for hypo-reflective spaces in the images, including sub- and intraretinal spaces, and quantified total retinal hypo-reflective space volumes. Both home and in-office OCT images were also graded by experts for detecting for hypo-reflective spaces in the intra- and subretinal compartments. The 2 key outcomes the study evaluated were; repeatability of the algorithm estimating total retinal hypo-reflective space volumes on home OCT images and the agreement between the AI and expert graders in segmenting hypo-reflective space…..

Read more: https://shorturl.at/ZadcY

Source: Ophthalmology Times

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