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HomeminewsHigh Tech Early Detection for Vision Loss

High Tech Early Detection for Vision Loss

Eyes at high risk of progression to choroidal neovascularisation (CNV) can be identified earlier, with significantly better levels of visual acuity maintained using a new device called ForeseeHome.

The ForeseeHome AMD monitoring program is a high-tech alternative to the Amsler grid, which is commonly used in the home by people with macular disease to detect any changes in vision. This prescription based, comprehensive telemonitoring and data management system extends the management of age-related macular degeneration to patients’ homes between visits to the ophthalmologist.

As we head into Macular Disease Awareness Week (24 to 30 May), Rob Cummins, Research and Policy Manager at Macular Disease Foundation Australia, says the device appears to be a useful, albeit expensive way to improve the early detection of changes that may indicate progression to wet age-related macular degeneration.

“It would appear to be a very worthwhile addition to the management of people with dry age-related macular degeneration. It would seem that the major negative is the cost, especially since the majority of people with high risk dry age-related macular degeneration do not progress to wet, and that progression can take many years, so the cumulative cost could become very significant. It is also unclear what the long-term compliance is at this stage, however if you’re paying for a service, one imagines that most people would tend to use it,” said Mr. Cummins.

A company spokesperson said patients needed to examine the benefit vs. cost of paying for the device. “It’s a safety net, or insurance policy to catch the progression to wet AMD at earliest stage before there is a significant loss of vision,” the spokesperson said.

Based on preferential hyperacuity perimetry, the ForeseeHome device identifies visual distortions and transmits results to a central monitoring centre that alerts the eye health professional.

A study conducted by the National Eye Institute demonstrated “that earlier detection of CNV could be achieved through home-monitoring strategies with ForeseeHome, with eyes achieving better levels of vision at the time of CNV detection when using ForeseeHome vs. standard care methods alone.” Standard care was defined as the use of an Amsler grid.

The randomised three year, phase three unmasked clinical trial, known as the
Home Monitoring of the Eye (HOME) study, was collaboratively undertaken with investigators of the AREDS2 study. It involved 1,520 participants with AREDS Category 3 and 4 dry eye age-related macular degeneration from 44 centres.

The study found that “94 per cent of ForeseeHome patients who used the device as directed and converted to wet AMD kept their functional vision vs. only 62 per cent of patients using other detection methods.”

Due to a positive finding, the Data Safety and Monitoring Committee recommended that the HOME Study be terminated because: “The demonstration of eyes at high risk of progression to CNV can be identified with significantly better levels of visual acuity when detected with ForeseeHome plus standard care vs. standard care alone at the interim analysis (approximately 80 per cent of the planned sample size).”

Additionally the researchers reported that 94 per cent of individuals with dry age-related macular degeneration at risk for progression to CNV were shown to maintain good, functional vision at the time of their CNV detection when using the ForeseeHome device as recommended. In multiple studies, patients who had a baseline VA of 20/40 or better at CNV diagnosis had better overall visual outcomes following anti-VEGF therapy compared to those patients who started anti-VEGF therapy at VA levels below 20/40.

They reported that ForeseeHome triggered, on average, one false-positive alert per patient every 4.2 monitoring years. Overall the ForeseeHome triggered 24 per cent false-positive alerts. “These 24 per cent of dry AMD patients may have had a statistically significant change in vision as detected by the ForeseeHome device that may be indicative of CNV. However, on the follow-up office visit, CNV may have been too early to detect by optical coherence tomography (OCT) or fluorescein angiography (FA).” The significant change was defined as “a change in a patient’s test results compared to a patient’s baseline testing results and a normative database of test results for AMD patients”.