Extremely encouraging results from two clinical trials at 28 opthalmic centers have led the U.S. Food & Drug Administration (FDA) to approve the first-ever implantable telescope for end-stage macular degeneration – severe vision loss or blindness due to a disorder of the central retina.
More than 1.7 million Americans over the age of 50 have experienced significant vision loss from advanced macular degeneration (AMD), which frequently leads to end-stage macular degeneration. About 50 percent of those with AMD are affected in both eyes.
The clinical trials for the eye telescope involved 219 telescope recipients, 90 percent of which were able to read at least two lines more on an eye chart. About 75 percent of the study participants progressed from severe vision impairment to moderate vision impairment.
The Implantable Miniature Telescope is intended for use in patients 75 years of age or older who need to have a cataract removed, and who have stable-severe to profound vision impairment (20/160 to 20/800). These levels of visual impairment typically indicate that a person is legally blind. The implantation of the telescope is performed as an outpatient procedure.
The procedure itself is not without some risk and the FDA requires an “acceptance of agreement” to be signed between patient and surgeon due to the potential for corneal damage and worsened vision. Thorough testing must also be done in order to determine if a patient is a candidate for the procedure.
If VisionCare, the company that pioneered the procedure, is able to successfully obtain patient coverage through Medicaid (the company has already applied for a code to establish this), seniors would be more likely to afford the procedure. The telescopic device itself costs $15,000, according to VisionCare.
There are two types of AMD, wet and dry. Wet AMD can progress to the point where there is scarring of the macula despite drug treatments, while dry AMD can progress to the point of geographic atrophy. Patients who have either of the two types of AMD can be potential candidates for the procedure.
VisionCare attempted for years to receive FDA approval for the telescopic device and procedure, but concerns about cornea damage that resulted during trials held up the approval process. As part of its agreement to approve the device and procedure, the FDA requires that VisionCare continue to heavily screen for suitable candidates, and that it provide thorough study results for the first 770 patients who undergo the procedure.
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