Home Optical Coherence Tomography Device Accurately Identifies Neovascular AMD

Laird Harrison

November 14, 2020

Patients can use an optical coherence tomography (OCT) device at home to accurately identify retinal fluid caused by neovascular age-related macular degeneration (nAMD), researchers say.

Paired with artificial intelligence (AI), the home OCT device could allow clinicians to monitor the fluid more continuously while reducing the number of office visits needed, said Anat Loewenstein, MD, MHA, from Tel Aviv University in Israel.

"The reason that it has such a good potential is that it tends to catch the fluid the day that it starts to accumulate and provide a lot of data to the physician," she told Medscape Medical News.

Loewenstein presented an assessment of Notal Vision's Home OCT at the virtual American Academy of Ophthalmology (AAO) 2020 annual meeting.

Many patients with nAMD have difficulty visiting their physicians' offices often enough to adequately monitor the progression of the disease. And the COVID-19 pandemic has increased the desire of both patients and healthcare workers to reduce the number of patient visits.

The small, portable Notal Home OCT has a 10° field of view (3 mm x 3 mm). It creates 88 B-scans with 34 µm of spacing.

To evaluate the performance of the new device, Loewenstein and colleagues scanned 69 eyes with wet or dry AMD in 45 patients with a mean age of 81 years, using a conventional OCT device (Cirrus or Spectralis).

Of those eyes successfully scanned, 8.7% had early AMD, 23.2% had intermediate AMD, and 68.1% had nAMD.

The researchers then provided the patients with a 2-minute instructional video and asked them to scan their own eyes using the home OCT devices. Ninety-three percent of the patients were able to scan their eyes successfully. The 7% who could not complete the imaging had a median visual acuity of 20/66, compared with 20/30 for those who could complete the imaging.

Of 37 patients who completed a survey about their experience with the home OCT device, 95% agreed or strongly agreed that the scan was "easy to perform."

Table. Home OCT Agreement With Conventional Scans

Parameter Agreement  
Subretinal fluid 93
No subretinal fluid 96
Intraretinal fluid 91
No intraretinal fluid 98

 

A masked reader then compared the images from the devices for the presence of intra- and/or subretinal fluid in the central 10° of the macula. There was a high degree of agreement between the home and conventional devices on all parameters.

Agreement with the conventional OCT scans increased when the patients made two images on the home OCT devices, and increased even more if they made three images.

Once the device becomes commercially available, an artificial intelligence program, the Notal OCT Analyzer (NOA), will analyze the images. If this program determines that the images show retinal fluid, it will send a report to the patient's physician.

The technology could also be used for diabetic macular edema, but it has not yet undergone validation for that indication, Loewenstein said.

"The business model is that it will not be sold, but rather prescribed, by the physician," Loewenstein said. "The reimbursement then comes from the insurance."

The cost of the devices and the willingness of insurance companies to reimburse for the scans will make a crucial difference, as each device will only monitor one patient, said John Miller, MD, from Massachusetts Eye and Ear in Boston. "The devices that we have in clinic are expensive, but they do monitor hundreds of patients over years so that cost is somewhat dissipated."

If the device does become available at a reasonable cost, it could provide patients with more timely treatments, potentially improving their vision, Miller said. "I’m very supportive of the concept and idea, and I'd love to use it in my patients."

American Academy of Ophthalmology (AAO) 2020 Annual Meeting: Session PA059. Presented November 11, 2020.

Loewenstein reports relationships to Allergan, Bayer Healthcare, Beyeonics, ForSight Labs, Notal Vision, Novartis, and Roche. Miller reports relationships with Zeiss and Heidelberg Engineering.

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