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Dry age-related macular degeneration (AMD) is one of the most common causes of vision loss in the United States. As an optometrist in a busy medically oriented practice, I have seen numerous patients with dry AMD lose vision between office visits over the course of my career. Often, these patients have been prescribed Amsler grid testing and AREDS nutritional supplements, according to the standard of care. As the medical professional responsible for helping my patients maintain functional vision, I have always felt that there is a need to do more.
I introduced the ForeseeHome at home monitoring device (FSH; Notal Vision) in my practice approximately 4 years ago. This device replaces the antiquated and subjective Amsler grid test, and provides patients with a convenient at-home testing solution capable of detecting progressive changes in vision that may occur between doctor visits.
TO THE POINT
A device for home monitoring of macular changes could allow patients with AMD to receive treatment in a more timely manner.
Dry AMD can progress to the more sight-threatening neovascular AMD, also known as wet AMD, very rapidly. Vision loss that occurs between office visits or by the time a patient notices a change using the Amsler grid can often lead to more severe vision loss and delayed treatment.1 Delayed treatment of wet AMD may lead to scarring and irreversible vision loss. With FSH, patients are doing the next best thing to coming in to my office on a daily basis. The early detection of macular changes secondary to wet AMD assures that my patients get the intervention they need in a timely manner, ultimately preserving functional vision.
CLINICAL TRIAL DATA
The efficacy of FSH was demonstrated in the Home Monitoring of the Eye (HOME) study, which was a substudy of the National Eye Institute’s second Age-Related Eye Disease Study, commonly called AREDS2. The HOME study compared vision outcomes in patients who progressed to neovascular AMD detected via the FSH arm (FSH + standard care) with patients whose disease was detected via standard care alone.2 Standard care included routine office visits and may have included an Amsler grid or the investigators’ instructions to their patients for detecting a change in vision between office visits. The study included 1520 intermediate AMD patients with visual acuity of 20/60 or better. The patients were instructed to test their eyes several times each week with the Amsler grid or FSH device.
An interim analysis of the HOME study, conducted at approximately 80% of the planned sample study, demonstrated such a significant difference between the FSH arm and standard care alone arm that the Data Safety and Monitoring Committee recommended the HOME study be terminated early so that all study patients could have access to the sight-saving FSH technology.
This analysis demonstrated that users who used the device as prescribed (at least twice per week) in the FSH arm from baseline to neovascular AMD detection showed a median loss of VA of 4 letters from baseline; a median loss of 9 letters was observed in the standard care alone cohort (P = .02). In addition, 94% of patients in the FSH arm kept their functional vision (≥ 20/40) at the time of wet AMD detection, compared with 62% of patients using other detection methods.
Implementing FSH into my practice involved training of my staff and technicians. All of our doctors and our technical staff know how to intelligently discuss this technology with patients. We explain that ForeseeHome is the industry leader when it comes to monitoring the macula; it is as close as we can get to the office-based preferrential hyperacuity perimetry (PHP) we use for diagnostic testing. We also explain that we will be monitoring the patient’s progress and request that the patient use the device as prescribed.
Prescribing FSH requires a completed order form stating that the patient has 20/60 or better BCVA and dry macular damage in one or both eyes. We submit the completed prescription form directly to Notal Vision. Medicare and most major medical insurance carriers provide coverage; however, on occasion additional documentation is required. Our patients are also provided an informational brochure about the device and details of the process of insurance verification, delivery, and setup. After the prescription form has been faxed to Notal Vision, the patient is notified by the company, and the device is delivered to the patient’s home. Setup of the device is completed remotely by Notal Vision and the patient’s baseline is established during the first 2 weeks of testing. All billing for the device and monitoring of the patient data is handled by Notal Vision.
The FSH requires a simple setup, and the first six to 12 consecutive tests establish the patient’s baseline. Visual function is measured during an interactive 3-minute-per-eye test performed by clicking in the location of a “wave” or bump on a dotted line that appears and disappears quickly to prevent fixation. Test results are transmitted automatically to Notal Vision and compared with the patient’s baseline and normative results to detect changes that may be indicative of progression from dry to wet macular damage.
In the event of a significant deviation from baseline, the prescribing physician receives a telephone or electronic alert. The patient can also receive the alert with the physician’s consent. We can act quickly to get the patient in the office to verify results and refer to a retina specialist if necessary. Additionally, Notal Vision sends a monthly report including a digitized metamorphopsia and scotoma grid plotting each patient’s testing results and patient usage data. With a quick look to check patient compliance and disease progression, I can have complete peace of mind. If there is a decline in the patient’s usage, Notal Vision will make a call to check on them. Patients appreciate the personal approach, and it creates a level of patient accountability, which has always been a challenge with standardized Amsler grid testing.
CASE IN POINT
We were able to preserve and restore vision in a patient in her mid-50s with BCVA of 20/20 and moderate dry AMD using the FSH. I received an electronic alert, and both the patient and I received a phone call notifying us that her test results showed a change that may have indicated progression from dry to wet AMD. A routine macular check and OCT scan confirmed there was fluid in her macula and BCVA had decreased to 20/40. I immediately referred her to a local retina specialist who confirmed the diagnosis of CNV. Our patient was treated with a series of three anti-VEGF injections, and I am happy to report that within 6 months she had regained BCVA 20/20 in the affected eye.
It is my responsibility as a primary care eye doctor to preserve vision. I feel strongly that the use of the ForeseeHome device is a leap forward in my ability to prevent vision loss. I treat every patient as I would a member of my family. I make strong recommendations in those patients who are most at risk for progression; and have found that it has been incredibly valuable. The testing is not difficult for the patient and compliance has been very high, with most patients using the device 4 to 6 times per week.
With the exception of office-based evaluation, there is nothing else in the industry that is as precise or as sensitive at determining changes in the health of the macula than the ForeseeHome device. It has made it possible for us to confidently monitor our patients until it is necessary for them to see a retinal specialist. I am able to reduce the burden of frequent office visits on my high-risk AMD patients by offering them the convenience of an at-home testing platform with potentially vision-saving benefits. Most importantly, I feel a lot more comfortable knowing that patients who are using the device will have the best opportunity for prompt intervention should they progress to wet AMD.
1. Schuchard RA. Validity and interpretation of Amsler grid reports. Arch Ophthalmol. 1993; 111(6):776-780.
2. AREDS2-Home Study Research Group; Chew EY, Clemons TE, Bressler SB, et al. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the eye (HOME) study. Ophthalmology. 2014;121(2):535-544.
Tim Earley, OD
• vice president and HR manager, Medina Vision and Laser Centre, Medina, Ohio
• financial disclosure: none relevant
• 330-722-2150; @tim_eyedoc; firstname.lastname@example.org