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Marcus T Altman, Merina Thomas, Voraporn Chaikitmongkol, Neil M Bressler; 5-Year Results of a Home Monitoring Device in Study Participants at High Risk for Neovascular Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2021;62(8):353.
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Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) is a leading cause of blindness, necessitating early treatment before significant vision loss occurs. The ForeseeHomeTM Preferential Hyperacuity Perimeter (PHP) is FDA-approved to aid in home monitoring for CNV related to AMD. A prospective cohort study evaluated how often home monitoring detects conversion to CNV in patients with intermediate AMD over a relatively long follow-up.
Patients were ≥55 years-old and had intermediate AMD with visual acuity ≥20/63 in the study eye. A previous study determined that an in-office qualifying test could identify patients most likely to use the PHP device successfully. Patients who qualified were then required to establish a baseline score at home with the device. If successful, the patient proceeded with daily home use. Patients were monitored for 5 years and could trigger an in-office visit by either a device alert or by reporting a visual symptom. If no CNV was detected at the visit, the patient could then re-establish a baseline with the device to continue home testing.
91 patients qualified for device use, with mean age of 73.1 years and visual acuity of 20/28. Of these, 132 study eyes established a baseline to begin home testing, with 54 eyes (41%, 95% CI 32%-50%) having at least one alert (by symptom and/or device) over 5 years of testing. Among 90 device-triggered visits, 83 (92%) were false positive, while 7 (8%, 95% CI 3%-15%) resulted in detection of CNV at mean 2.1 years following enrollment. Two eyes that developed CNV were diagnosed by symptom only without a device alert (2 of 9 total CNV cases; 22% false negatives, 95% CI 3%-60%). Mean visual acuity at time of CNV detection was ~20/32. 23 eyes that had a false-positive alert withdrew from the study due to a failure to re-establish baseline—of these, 6 (26%) developed CNV on average 2.7 years later. Mean monthly device usage was 15 times per month and was higher in the first year of an eye’s enrollment versus the fifth year (18.5 vs 12.8 uses per month, difference = 5.7, 95% CI: 3.5-7.9; P<.001).
These data over 5 years suggest a large proportion of incident neovascular AMD cases were detected by home monitoring, and eyes monitored by the device had good visual acuity at time of CNV detection. In this study, the device showed a 22% false negative rate.
This is a 2021 ARVO Annual Meeting abstract.
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