Session Title: AMD I
Session Date/Time: Friday 12/09/2014 | 08:00-10:00
Paper Time: 09:28
Venue: Boulevard C
First Author: : U.Chakravarthy UK
Co Author(s): :
To determine whether home monitoring with the ForeseeHome device (Notal Vision Ltd, Israel), using hyperacuity visual field and telemonitoring, results in earlier detection of age-related macular degeneration–associated choroidal neovascularization (CNV), when compared with standard care.
A subset of clinical centres in the age-related eye diseases II clinical study
1,970 participants age 53 to 90 years at high risk of developing CNV were screened. Of these, 1520 participants with a mean age of 72.5 years were enrolled in the HOME study at 44 AREDS2 clinical centers and randomized to two arms. Instructions were provided to participants in both arms for self-monitoring vision at home followed by report of new symptoms to the clinic. Participants in the device arm were also asked to perform daily device testing. When prompted by changes in device test results the device monitoring center contacted clinical centers, which contacted participants for examination. The primary outcome was the difference in best-corrected visual acuity between baseline and detection of CNV. CNV events were determined by investigators using FA and OCT. A secondary outcome compared the productivity of various alerting modalities in detecting CNV.
Mean follow-up was 1.4 years between July 2010 and April 2013. At the prespecified interim analysis, 82 participants progressed to CNV, 51 in the device arm and 31 in the standard care arm. Participants in the device arm had a smaller decline in visual acuity from baseline to CNV detection (median, -4 letters; interquartile range [IQR], -11.0 to -1.0 letters) compared with standard care (median, -9 letters; IQR, -14.0 to -4.0 letters; P = 0.021). The Data and Safety Monitoring Committee recommended early study termination for efficacy. During the analysis period, participants in the device arm had 263 device alert visits, 55 visits prompted by symptoms and 1927 standard care office visits. CNV was diagnosed at 26, 11 and 14 of these visits, respectively. CNV events were diagnosed at 10%, 20%, and 0.7% of device alerts, symptom alerts and standard care visits, respectively.
Persons at high risk for CNV benefit from the home monitoring strategy for earlier detection of CNV. The productivity of an office visit prompted by a device alert is far greater than a routine office visit in identifying new onset CNV.