Dr. Regillo and other study investigators theorized that by using the device, patients would be able to identify the presence of choroid neovascularization (CNV) early and take advantage of appropriate treatment to arrest disease progression at an early stage when visual acuity is often good.
The importance of this early identification is underscored by the AREDS results (the AREDS 11 Report) that determined of about 8 million patients with intermediate- to high-risk AMD, about 670,000 will progress to CNV over a period of 5 years after treatment was started.
Of those patients, about 77% may qualify to use the home monitoring device. When patient noncompliance is factored in—estimated to account for about 10% of patients—more than 400,000 patients may use home monitoring over a period of 5 years, with a resultant additional 100,000 maintaining 20/40 or better visual acuity at the time of neovascular AMD detection.
The combination strategy of a home monitoring device and the Amsler grid—considered the standard of care—resulted in a larger proportion of study eyes with intermediate AMD maintaining vision of 20/40 or better, i.e., 87%, at diagnosis of CNV compared with study eyes evaluated with only the Amsler grid, 62%.
These results were applied to estimates of the U.S. population at high risk of developing late AMD to estimate the potential public health effect of home monitoring with the device.