Tiny eye implant might soon make a huge difference

Many people with advanced macular degeneration, a leading cause of blindness in the elderly, can learn to use their eyes in a new way with an implantable telescope, a first-of-its-kind device recently approved by the Food and Drug Administration and on its way to Long Island in coming months.

The implant, which replaces the eye's lens, helps those who were legally blind resume reading, recognize faces, and perhaps for the first time in years, increase their degree of independence.

Long Island is one of 14 initial sites nationwide where doctors will implant the miniature quartz-glass instrument, developed to combat the worst stage of a disease that destroys the macula, the light-sensitive cluster of cells in the retina at the rear of the eye.

Macular degeneration primarily affects people 55 and older, impairing vision by leaving a huge dark spot in the middle of the visual field. Those with end-stage disease are legally blind.

Based on design principles of celestial telescopes that scan the stars, the implant aids vision but is not a cure. The device directs light and images over a wide angle onto remaining healthy portions of the retina. The dark spot doesn't disappear, doctors say, but with more of the retina in use, visual acuity can improve despite it.

"The results can be miraculous for some patients. We're not giving them back vision, we're just working around [the disease] in a new way," said Dr. Julia A. Haller, chief ophthalmologist at the Wills Eye Hospital in Philadelphia, who recruited patients into clinical investigations of the device.

Unlike the crystalline lens implanted during cataract surgery that helps the eye focus light, the telescope, Haller said, amplifies the size of objects in the patient's visual field.

Someone with an implant would not be able to drive, but might be able to resume cooking, choosing clothes without assistance, or using a computer equipped with a low-vision program.

In the clinical trial of 219 people who received the implant, 90 percent could read two lines or more on an eye chart. And 75 percent could also do tasks such as read large-print books, which would reclassify them from severely impaired to moderately impaired.

Huge help for sports fan

"Here's the difference with this device," Haller added. "One of my patients is a big sports enthusiast - hockey, baseball, you name it. He loved going to games and watching them on TV. But when his disease worsened, he could only listen to them on the radio. Now he can watch sports on TV again. To most people, watching TV isn't a big deal. To these people, it's huge."

Still, the device doesn't produce entirely normal vision. It's implanted in only one eye of those who have advanced disease in both. The eye left alone is used for peripheral vision, which the implant cannot provide. Patients have to adapt to the difference, so much so that a rigorous training and counseling program was developed to help them learn to see in a new way.

What's more, researchers say, there is a chance that the device can injure the cornea. The eyes of five of the 219 subjects in the clinical trial were damaged so severely that cornea transplants were necessary. Some experts have called for a comparative study of the implant and telescopes mounted on eyeglasses to determine which of the two works better.

Anyone who has had cataract surgery is not eligible to get the implant.

Still, the telescopic lens represents a chance for improved vision among those with end-stage macular degeneration, for which there has been no effective treatment. Medications, including the newly approved Genentech drug Lucentis, injected directly into the eye, are options to arrest one form of the disease in patients whose condition is less severe.

The lens implant is expected to cost around $15,000, but that doesn't include surgical and other medical costs, which have yet to be determined. The quartz glass from which it's fabricated is designed to last for the patient's life, and California-based manufacturer VisionCare Ophthalmic Technologies Inc. is seeking Medicare approval for the implant.

Ophthalmic Consultants of Long Island, which has offices in Nassau and Suffolk, will be the first Island center to offer the miniature telescope, probably within the next four to six months, said VisionCare vice president Chet Kumar.

The implant is restricted to patients 75 and older, in keeping with FDA approval guidelines. Within months after it is introduced here, the device will be made available to more ophthalmic practices, clinics and hospitals, Kumar added.

Many waiting for help

"I have a lot of people who are waiting to be screened and they seem to be in the ballpark of those who would make good candidates," said Dr. Glenn Stoller, an ophthalmologist at the practice who specializes in retinal disorders.

Ronald Longarzo, 93, of Valley Stream, said he has been told that he may be a good candidate. "I could certainly use it because my vision has gotten pretty bad," said Longarzo, who has had macular degeneration for 20 years and lives alone.

Dr. Brett Rosenblatt, a retinal specialist at Long Island Vitreoretinal Consultants, which has offices in Nassau, Suffolk and Queens, said many patients have asked about the device.

While doctors at his practice will not implant it, they likely will screen patients and recommend them to the surgeons who do.

"I think this is great technology, but you have to select the right patient for it," Rosenblatt said.

Approved by the FDA last month, the implant must undergo two additional studies, according to the agency. One is follow-up research on people who've already received the implant. The other involves 770 test subjects who are to be enrolled in a new study to examine cornea-cell density.

The agency's approval came after an FDA advisory panel, composed of vision experts not connected with the agency, voted unanimously in favor of the implant in March.

Panelist Dr. Janet Szlyk, executive director of the Chicago Lighthouse for People Who Are Blind or Visually Impaired, said the committee voted for approval because other than hand-held magnifiers or telescopes mounted on eyeglasses, there were no options for those with end-stage macular degeneration.

First implanted device

"This is the first visual prosthetic device [for macular degeneration] that is actually implanted," said Szlyk, who calls the age-related disease a crisis that will only worsen as the baby boomer population grows older.

"It's an epidemic because we are outliving our retinas," she said.

An estimated 8 million people in the United States have macular degeneration, according to the National Eye Institute, and nearly 2 million of them have significant vision loss, making it difficult for them to recognize faces.

"It's about the size of a pea and has to be that small so it can fit inside an eyeball," Stoller said of the telescopic implant.

Ed Nungesser, 72, of Philadelphia, who received the device during clinical trials, can now use a computer. "My vision is 1,000 percent better. I now have just about total use of my right eye - that's the implanted eye," Nungesser said. "Before the implant was done, I was blind in that eye." 

What is Macular degeneration?

-Macular degeneration is an age-related disease that affects those 55 and older.

-It destroys the eye's macula, the light-sensitive cluster of cells in the retina at the rear of the eye.

-People with the condition can see only fragments before them, with a large black spot in the middle of their field of vision. In its most advanced stages, the spot widens and wipes out most of the visual field.

-There are two forms of macular degeneration, wet and dry. The wet form is caused by blood vessels that leak in the retina, destroying the retina and causing scar tissue. The dry form is characterized by the accumulation of debris called drusen and retinal detachment.