Real-World Performance of a Self-Operated Home Monitoring System for Early Detection of Choroidal Neovascularization in AMD (ForeseeHome device)

Abstract

Purpose : Evaluation of real-world (RW) performance of a monitoring strategy with an FDA-cleared, self-operated home monitoring system on top of standard care, for early detection of choroidal neovascularization in AMD (ForeseeHome device, Notal Vision Inc), compared to performance in the NEI sponsored HOME study and AAO’s IRIS registry.

Methods : A retrospective review of dry AMD patients participating in the ForeseeHome (FSH) device monitoring program was performed by an Independent Diagnostic Testing Facility (Notal Vision Diagnostics Center) from 11/2009-09/2018. All subjects were monitored with the FSH device. Subjects with documented development of choroidal neovascularization (CNV) in one or both eyes were identified. Data related to the CNV event were collected, including modality of CNV diagnosis (device alert vs detection by other standard care means), and Snellen visual acuity (VA) at baseline and at CNV event. These data were compared with data from the HOME study and the IRIS registry.

Results : In these FSH-monitored patients, 306 CNV events were recorded; 211 (69%) detected after FSH alert. For all eyes with known VA, baseline VA (median) was 20/25-2, and at event 20/32-2. For eyes with events detected with FSH, baseline VA was 20/32+2 and at event 20/40+2. VA change was similar (p = 0.35) when events were detected by other means (i.e. through symptoms/during routine office visits), with VA median loss of 4 letters. % of all eyes with baseline VA>=20/40 retaining >=20/40 vision at event was 80%, 82% for eyes detected with FSH, and 74% detected by other means. These data are comparable to the HOME study, where 64.1% of CNV events were detected after FSH alert, with baseline VA 20/32+2, event VA 20/40+2, median VA loss of 3 letters and 91% of eyes maintaining VA >=20/40. These data are substantially better than real-word IRIS registry data in which the reported VA at CNV event is 20/80 with only 33% of eyes maintaining VA>=20/40.

Conclusions : RW performance of the strategy including the FSH Monitoring System is comparable to its performance in the HOME study. Coupled with standard of care, its usage demonstrated a substantial benefit to patients by helping preserve an additional 3 lines of vision at the onset of CNV, as compared to standard-of-care alone in real-world IRIS data, leading to excellent VA prognosis with current therapy.

This is a 2020 ARVO Annual Meeting abstract.