Home OCT Images Suitable for Fluid Detection

An at-home optical coherence tomography (OCT) imaging system is capable of producing high quality images in 91% of participants, and shows a 97% positive agreement with commercial in-office OCT, according to research published in BMC Ophthalmology.

In this cross-sectional study, researchers set out to assess the accuracy of the Notal Vision Home OCT (NVHO) as it compares with commercial OCT imaging. Data was collected during 2 separate trial periods; September 2018 to February 2019 using NVHO 2.5, and December 2019 to February 2020 using NVHO 3.0. In both trials, participants were required to have a previous diagnosis of neovascular age-related macular degeneration (nAMD), Snellen visual acuities (VA) of 20/400 or better, and the ability to sustain commercial OCT and NVHO imaging. All imaging was completed at an ophthalmology clinic with NVHO imaging conducted while a technician was present. Images were analyzed using the manufacturer signal quality index (MSI). Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated to compare commercial OCT imaging with NVHO imaging. 

In NVHO 2.5 trials, 290 patients (560 eyes) attempted self-imaging. The images were successful in 469 (88%) of those eyes (91% of participants). The 9% who could not complete self-imaging had a mean age of 84.3±7.8, and 56% were women. Those who did complete it had a mean age of 78.8±8.8, and 58% were women. Also, of those who successfully conducted the imaging, 38 (8.1%) had early AMD, 121 (25.8%) had intermediate AMD and 310 (66.1%) had nAMD.

The NVHO 3.0 trials included 74 eyes of 45 participants (mean age 79.5±6.5 years, 51% women, median VA 20/30). The research shows 69 eyes of the 45 participants completed self imaging (For the 5% of eyes that were not imaged successfully, patients had a mean age of 84.0±1.4 and 40% were women). Diagnostic statistics for this group were similar to the NVHO 2.5 group. 

The NVHO 3.0 trial was conducted in a different manner in that participants performed 5 imaging sessions each over a long period of time, rather than a single session each. In total, this trial shows 336 self-images were performed in 69 eyes of 45 participants spanning 89 total visits. In 87.7% of these visits, at least 4 self-images were achieved and gradable, the study says. 

The PPA/PNA was 98%/96 for NVHO 2.5 and 97%/95 for NVHO 3.0, respectively. The diagnostic accuracy was not dependent on participant VA in either trial.

Of the 469 eyes that had images acquired using the NVHO 2.5, 99% were gradable by an ophthalmologist (compared with 99.8% of images derived from a commercial OCT that were gradable). 

“The self-operated OCT device image quality compared favorably to the commercial OCT, suggesting that this planned device may be able to complement standard-of-care clinical assessments and treatments,” researchers speculate. 

The NVHO 3.0 study is limited by its small sample size. Additionally, both studies recorded the self-assessment of the NVHO in the presence of a trained technician and all participants had VA of greater than 20/40, possibly affecting the accuracy level found for each device. 

Disclosure: This research was supported by Notal Vision Ltd. Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Kim JE, Tomkins-Neter O, Elman MJ, et al. Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. BMC Ophthalmol. 2022;22: 261. doi:10.1186/S12886-022-02458-Z