There’s new hope for patients with Age-related Macular Degeneration (AMD) today.
An Implantable Miniature Telescope (IMT) has been approved by the U.S. Food and Drug Administration. The device is a small telescope that is implanted into one eye, replacing the natural lens. The telescope magnifies images 2.2 to 2.7 times.
AMD mainly affects older people. It damages the center of the retina (macula) and causes a loss of vision in the center of the visual field. About 8 million people in the United States have AMD with 2 million of them having significant vision loss. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television, according to the National Eye Institute.
The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD.
Only one eye receives the implant. The other eye is used for peripheral vision. Patients must undergo pre-operation training with an external telescope to test adaptability and the peripheral vision in the other eye. They must also agree to post-operative training.
In a 219 patient, multi-center clinical study of the IMT, 90% of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity. 75% of patients improved their level of vision from severe or profound impairment to moderate impairment.
As a condition for the FDA approval, the devices manufacturer, VisionCare Ophthalmic Technologies Inc., has agreed to additional post approval studies and patient follow ups.