The Only Treatment For End-Stage AMD

September 1, 2011

Like something more science fiction than science, VisionCare Ophthalmic Technologies has developed an implantable miniature telescope (IMT) to improve vision in patients with end-stage age-related macular degeneration (AMD). This tiny device, about the size of a pea, is like a classic Galilean telescope but meant to be put inside the eye. Its lenses, like those of a classic telescope, cause images to be focused away from the diseased macula at the back of the eye, toward areas of healthy retina. This allows a significant improvement in vision.

The implantable miniature telescope was designed by Dr. Isaac Lipshitz and was approved by the FDA in July 2010 after successful clinical trials. In one multicenter trial, 90% of patients gained at least a two-line improvement in their vision. This means that they went from severely or profoundly vision impaired (legally blind) to moderately impaired, an amount of improvement that can mean regaining the ability to read, watch television and live alone. These are compelling results with exciting potential.

The telescope, the only treatment for end-stage AMD, was designated a "Best of What's New" in 2010 by the magazine Popular Science.

The telescope uses wide-angle micro-optical elements. Because it is implanted into the eye's own lens pocket, it moves naturally. The telescope must be implanted into an eye with a healthy cornea, which is part of the eye's refracting system. The cornea and the telescope work together, creating a telephoto system that magnifies any objects in front of the eye. The implantable telescope comes in two models. One magnifies images 2.2 times, the other 2.7 times.

The magnification, along with focusing the image on the healthy outer parts of the cornea, allows patients with significant macular degeneration to get clearer vision from parts of the retina that do not naturally provide sharp vision. The patient's other eye does not receive a telescope so that the rest of the retina in that eye can provide side or peripheral vision.

Some 8 million people in the United States have AMD, which can be "wet" or "dry." As many as 2 million have significant vision loss. There are medical treatments for earlier stages of the disease, but nothing is curative. When the disease advances enough to be called end-stage, it means that there is no further drug treatment that can be used. Some, but not all, people with end-stage AMD are candidates for the telescope.

In addition to having end-stage AMD and a severe to profound vision loss, to be considered for the implant, patients have to meet other criteria. They must have a healthy cornea. They must not have had cataract surgery, because the lens will be removed during the surgery and the lens capsule must be normal and intact. Patients must be at least 75 years of age.

If an ophthalmologist confirms that a patient meets the requirements, the next step is trying out a simulation of the telescope vision. A candidate must also undergo visual training and rehabilitation evaluations. The ophthalmologist will then be able to say whether or not a patient is likely to benefit from the telescopic implant or not, and if so, which eye should be used.

The surgery itself is an outpatient procedure that lasts only an hour. Implantation of the telescope is not without risks. There can be inflammation and deposits on the device itself. The pressure inside the eye can increase. There can be varying degrees of corneal damage that can decrease visual acuity and necessitate a corneal transplant. After a successful procedure, patients must undergo training to best use the IMT.

Patients must be informed of all the risks of this procedure. VisionCare Ophthalmic Technologies must also continue to monitor recipients of the IMTs over the next two to five years. The results to date have been impressive.

"This micro-optical telescope is a medical marvel not only because it is a tiny Galilean telescope we can implant inside the eye, but because it can help our most severely visually impaired AMD patients gain meaningful vision," said Kathryn A. Colby, MD, PhD, ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and an Assistant Professor of Ophthalmology at Harvard Medical School.

Retina Institute of Hawaii is looking forward to providing this surgery for eligible patients toward the end of 2011.

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