key: cord-356223-8qn164k5 authors: Yu, Hannah J.; Kiernan, Daniel F.; Eichenbaum, David; Sheth, Veeral S.; Wykoff, Charles C. title: Home Monitoring of Age-Related Macular Degeneration: Real-World Utility of the ForeseeHome Device for Detection of Neovascularization date: 2020-08-15 journal: Ophthalmol Retina DOI: 10.1016/j.oret.2020.08.003 sha: doc_id: 356223 cord_uid: 8qn164k5 PURPOSE: To evaluate real-world utility of the ForeseeHome monitoring device for the detection of conversion from intermediate age-related macular degeneration (iAMD) to neovascular AMD (nAMD) and compare with results published by the HOME study. DESIGN: Retrospective analysis of electronic health records. SUBJECTS: Eyes prescribed use of the ForeseeHome device across 4 retinal practices in the USA. METHODS: Usage information was collected from the online ForeseeHome portal for all eyes prescribed. For a pre-determined subset of eyes, additional clinical information was collected through chart review and analyzed for clinical utility. MAIN OUTCOME MEASURES: Outcome measures include frequency and length of use, number of eyes that used the device, established baseline and converted to nAMD, and number of alerts. RESULTS: 775 eyes of 448 patients were prescribed use of the ForeseeHome device. 649 eyes (83.7%) used the device at least once; among this population, 478 (73.7%) established baseline. Patients who established baseline were significantly younger than those who did not establish baseline (p<0.001). Among eyes that established baseline, 126 (26.4%) had an overall inadequate frequency of use (≥2 tests per week), and 250 (52.3%) did not use the device as frequently as instructed by the manufacturer (≥3 tests per week); 112 (24.7%) discontinued use within one year. Over a mean of 20.35 months, 106 patients had 152 alerts, indicating possible conversions to nAMD. Out of the 136 eyes that established baseline among 211 eyes prescribed the device at one clinical site, 52 alerts were recorded, 3 (6.8%) correctly identified conversion to nAMD and 47 (93.2%) represented false-positive alerts. CONCLUSIONS: Compared to the prospective HOME study, utility of the ForeseeHome device in the current analysis of real-world clinical-practice application was limited. A meaningful proportion of eyes never used the device or could not establish baseline. Overall frequency of use was low and continuous usage of the device decreased over time. There is a need for improvement in home monitoring technology for eyes with iAMD at risk of conversion to nAMD. Although this is still a widely used method of self-monitoring, it has shown low levels of 118 sensitivity and poor patient compliance. 32,33 More recent technology, however, has 119 shown promise in the use of daily home telemonitoring of iAMD. In 2014, the HOME study reported beneficial results from a randomized trial using the 122 ForeseeHome device (Notal Vision Ltd, Tel Aviv, Israel) for early detection of 123 conversion to nAMD. 34 The purpose of the current analysis was to determine the compliance of patients For each patient, the eye prescribed, age at first use, length of use, days since last 159 exam, total number of tests, ability to establish baseline, alert number and alert types 160 were collected from the ForeseeHome portal (www.foreseehomeonline.com). Eyes 161 were considered "active" if they had a test within 30 days of January 3, 2020. Eyes 162 classified as "never used" included eyes that never filled their prescription and eyes that 163 filled their prescription but never used the device. Overall frequency of use over total 164 length of use was calculated from the total number of tests and the length of use. in the month before the alert was also captured. Two frequencies of use were calculated 174 to investigate compliance: "adequate" frequency was defined by the HOME study at ≥2 175 tests per week; "instructed" frequency was defined at ≥3 tests per week as specified by proportion of eyes that could not establish initial baseline, mean frequency of use, mean 202 age, proportion of subjects within the HOME study age range, proportion of subjects 203 within the HOME study VA range, and proportion of OD study eyes. Chi square tests 204 were performed to test for significant differences among proportions and 1-way analysis 205 of variance (ANOVA) was used to test for significant differences among mean values. A 206 p-value less than 0.05 was considered statistically significant and a t-test distribution 207 was used to calculate 95% confidence intervals (CI). for ≥1 year, 24.7% stopped before 1 year; among eyes with the potential to have been 235 tested for ≥2 years, 13.8% stopped between 1 and 2 years; among eyes with the 236 potential to have been tested for ≥3 years, 13.8% stopped between years 2 and 3. The current study demonstrated a higher rate of false-positive alerts per patient per year 355 than did the HOME study. The HOME study reported 0.24 false alerts per person per OCT technology is that the assessment of meaningful change will be passive following 407 patient initiation of the at-home test. This would eliminate the limitation of patient data 408 entry from which ForeseeHome and many other home monitoring devices suffer. 409 Finally, increased understanding of the reasoning behind patient noncompliance may 410 help aid in the creation of optimal telemonitoring devices. difficult to evaluate how compliance with device usage was encouraged by physicians 420 and staff longitudinally. It is also unknown how thoroughly patients were pre-screened 421 before prescription of the device for their ability to use a computer mouse. The cost of 422 the device for each patient was also not assessed and the influence of cost could not be 423 evaluated. Additionally, eyes that were classified as "never used" did not distinguish 424 whether patients had never filled their prescription or filled their prescription and never 425 used the device. 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