Safety and Feasibility of a Novel Sparse Optical Coherence Tomography Device for Patient-Delivered Retina Home Monitoring

Peter Maloca, Pascal W Hasler, Daniel Barthelmes, Patrik Arnold, Mooser Matthias, Hendrik P N Scholl, Heinrich Gerding, Justus Garweg, Tjebo Heeren, Konstantinos Balaskas, J Emanuel Ramos de Carvalho, Catherine Egan, Adnan Tufail, Sandrine A Zweifel, Peter Maloca, Pascal W Hasler, Daniel Barthelmes, Patrik Arnold, Mooser Matthias, Hendrik P N Scholl, Heinrich Gerding, Justus Garweg, Tjebo Heeren, Konstantinos Balaskas, J Emanuel Ramos de Carvalho, Catherine Egan, Adnan Tufail, Sandrine A Zweifel

Abstract

Purpose: To study a novel and fast optical coherence tomography (OCT) device for home-based monitoring in age-related macular degeneration (AMD) in a small sample yielding sparse OCT (spOCT) data and to compare the device to a commercially available reference device.

Methods: In this prospective study, both eyes of 31 participants with AMD were included. The subjects underwent scanning with an OCT prototype and a spectral-domain OCT to compare the accuracy of the central retinal thickness (CRT) measurements.

Results: Sixty-two eyes in 31 participants (21 females and 10 males) were included. The mean age was 79.6 years (age range, 69-92 years). The mean difference in the CRT measurements between the devices was 4.52 μm (SD ± 20.0 μm; range, -65.6 to 41.5 μm). The inter- and intrarater reliability coefficients of the OCT prototype were both >0.95. The laser power delivered was <0.54 mW for spOCT and <1.4 mW for SDOCT. No adverse events were reported, and the visual acuity before and after the measurements was stable.

Conclusion: This study demonstrated the safety and feasibility of this home-based OCT monitoring under real-life conditions, and it provided evidence for the potential clinical benefit of the device.

Translational relevance: The newly developed spOCT is a valid and readily available retina scanner. It could be applied as a portable self-measuring OCT system. Its use may facilitate the sustainable monitoring of chronic retinal diseases by providing easily accessible and continuous retinal monitoring.

Keywords: age-related macular degeneration; monitoring; optical coherence tomography; retina.

Figures

Figure 1
Figure 1
Comparison of standard Heidelberg Spectralis desktop OCT to novel investigational spOCT. (A) Scanning laser ophthalmoscopy (SLO) of AMD. (B) Corresponding cross-section scan of the same eye as in (A) with illustration of manual central retinal thickness (CRT) measurement of standard Spectralis OCT (B) and spOCT (C). Note that in the spOCT system the scan resolution, thus the redundancy of image information, is reduced to allow rapid and repeated measurement of OCT volumes. However, despite the low sampling, CRT measurement was achieved in spOCT images comparable to the reference device.
Figure 2
Figure 2
Illustration and performance of the novel sparseOCT device (spOCT, MIMO_02) compared to standard Heidelberg Spectralis desktop OCT. (A) Illustration of the complete prototype spOCT (black box) shows compact design and novel headrest position to reduce moving artifacts. (B) The direction of the light beam can be adjusted to the position of the subject to provide a comfortable user experience. High sample recording of the single line scan of a healthy macula obtained by spOCT (C) compared to Heidelberg desktop OCT (D) of the same eye with comparable scan settings.
Figure 3
Figure 3
Bland-Altman plot of difference against the mean of spOCT scanner and Heidelberg Spectralis (reference) measurements of CRT (μm). The lines represent mean difference (solid) and mean ±1.96 standard deviations (dashed) as the 95% limits of agreement. Sixty-nine percent of the differences are in the range of ±20 μm (dotted lines).

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