The results of the HOme Monitoring of the Eye study, a subset of the Age-Related Eye Disease Study 2 (AREDS2), were presented last week at the Annual Meeting of the American Academy of Ophthalmology (AAO) in New Orleans, Louisiana, November 16-19, 2013.
The study revealed that participants at high risk for developing wet (or neovascular) age-related macular degeneration (AMD) who used the ForeseeHome AMD Monitoring Program and device (pictured at left) had significantly better preservation of visual acuity when their AMD progressed from dry to wet than the control group of participants who were using standard care methods alone to self-monitor the progression of their AMD.
About the ForeseeHome AMD Monitoring Program
The ForeseeHome AMD Monitoring Program was developed by Notal Vision, Ltd. The company was founded in 2000 and is based in Tel Aviv, Israel, with additional offices in Israel and the United States.
The ForeseeHome AMD Monitoring Program is a prescription-based, comprehensive telemonitoring and data management system that (a) extends the management of AMD to patients’ homes between office visits, (b) provides access to both patients and physicians to monitor AMD progression, and (c) alerts physicians to immediate, significant visual field changes in their patients, so that timely follow-up and treatment can be initiated.
To monitor AMD progression, the patient checks his or her vision once a day at home, via a non-invasive three-to-four minute test for each at-risk eye, using the ForeseeHome AMD Monitor. The test results are sent immediately via phone line or modem to the Notal Vision Data Monitoring Center (DMC), which provides live, ongoing monitoring.
The DMC then posts the patient’s daily test data on a secure website where his or her physician can review it at any time. In the case of a statistically significant change in visual acuity test scores, both the patient and doctor are notified immediately to schedule an appointment.
You can view the operation of the ForeseeHome AMD Monitor at YouTube.
Dry and Wet Age-Related Macular Disease
There are two types of AMD: dry (atrophic) and wet (neovascular or exudative). Most AMD starts as the dry type and in 10-20% of individuals, it progresses to the wet type. Age-related macular degeneration is always bilateral (i.e., occurs in both eyes), but does not necessarily progress at the same pace in both eyes. It is possible to experience the wet type in one eye and the dry type in the other.
Dry AMD
The dry (also called atrophic) type of AMD affects approximately 80-90% of individuals with AMD. Its cause is unknown, it tends to progress more slowly than the wet type, and there is not – as of yet – an approved treatment or cure; however, there are clinical trials underway.
In dry macular degeneration, small white or yellowish deposits, called drusen, form on the retina, in the macula – the small sensitive area in the center of the retina that provides clear central vision – causing it to deteriorate or degenerate over time.
A retina with drusen
Drusen are the hallmark of dry AMD. These small yellow deposits beneath the retina are a buildup of waste materials, composed of cholesterol, protein, and fats. Typically, when drusen first form, they do not cause vision loss. However, they are a risk factor for progressing to further vision loss from wet AMD.
Wet AMD
In wet macular degeneration, the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal blood vessels that develop into a cluster under the macula (called choroidal neovascularization).
The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.
The Study and Results
The The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD using the ForeseeHome Device was a collaborative effort led by the National Eye Institute (NEI) to evaluate the performance of the home monitoring device plus standard care compared to standard care monitoring alone for the detection of AMD progression to the neovascular phase.
Here is further background on the study/clinical trial from NEI:
In the wet form of age-related macular degeneration (AMD), new blood vessels grow and cause fluid leaks into the retina, which leads to loss of vision. Some studies suggest that if the development of new blood vessels (choroidal neovascularization, or CNV) is detected early, treatment could be started sooner, which may help prevent visual loss.
One possible method of early detection is the ForeseeHome device, which is part of a program designed to allow individuals to monitor their eyes for vision changes at home. Researchers are interested in comparing eye disease progression in people using the ForeseeHome device with those not using the device.
The results of the HOME study show that 94% of participants with high risk for developing [wet AMD] maintained 20/40 vision or better at the time they were diagnosed while using ForeseeHome … compared to 62% in the standard care alone group.
Also, in contrast to current home monitoring strategies, those with intermediate AMD (bilateral large drusen) or advanced AMD in one eye are likely to benefit from home monitoring with the ForeseeHome device to detect the development of [wet AMD] at an earlier stage with better preservation of their visual acuity.
Additional Information
For more information about the ForeseeHome AMD Monitoring Program, you can visit the ForeseeHome website. VisionAware will continue to provide updates of this macular degeneration research as they become available.