Last year the FDA granted de novo authorization to Notal Vision’s patient-operated Scanly Home OCT device, which operates in conjunction with the company’s own AI-based Notal OCT Analyzer (NOA) to automatically grade self-administered images taken by the home OCT. The FDA clearance marked the first-ever approval of an AI algorithm for OCT images.
A couple of months before, Ophthalmology Science published a pivotal trial seeking to validate the performance of the Analyzer, specifically for neovascular age-related macular degeneration (nAMD). In this trial the authors concluded that “the performance of NOA supports the intended use of the system as a tool to monitor TRO [total retinal hyporeflective] at home between routine clinical visits in support of the management of nAMD” and was influential in getting the de novo authorization.
However, to achieve FDA clearance – as explained by Nancy Holekamp and Eric Schneider in an interview with The Ophthalmologist – there were a few negotiations as to the semantics involved. Namely, the term “total retinal hyporeflective” (TRO) volume – clinically equivalent to intra- and subretinal fluid – was requested by the FDA in the wording used by the studies.
The introduction of this novel terminology was because, as Holekamp noted during the interview, “the FDA resisted conversations about fluid because no one proved to the FDA that we were actually measuring fluid.” “Not all fluid is hyporeflective on OCT and there are some hyporeflective spaces that don’t represent exudative fluid,” added Schneider, “and so we had to be more specific about what was being segmented.”
Semantics aside, since the FDA approval’s there have been a couple of other studies examining the efficacy of home OCT use. The two studies – one published in Journal of ViteroRetinal Diseases and one in Retina – both had Holekamp involved in some capacity, and both leaned favorably towards the use of home OCT in patients’ homes.
However, it remains to be seen how the technology will work in real world practice when – and if – it’s finally rolled out across the US. Schneider believed “inertia” to be one of the main barriers towards widespread adoption by clinicians – “People are very used to doing things the way they have always been done” he observed during our interview.
Financial concerns were also cited as affecting how ophthalmologists might respond to the device: “A lot of retinal specialists are concerned about the impact home OCT will have on the value of in-office diagnostics,” he said, “but many of those same providers don’t realize the added value of new codes in our specialty. New codes allow for additional reimbursement via coding for both in-office OCT and home monitoring.”
Medicare has yet to get the reimbursement code, but when it does, presumably private insurers will also follow suit. When this happens, it’ll be interesting to see just what the future holds for home monitoring for retinal disease patients in a real world setting. I, for one, am curious to see how exactly it might benefit both patients and ophthalmologists.
