Duke University Hospital becomes test site for first ‘bionic eye’

Jul. 13, 2013 @ 10:11 PM

Duke University Hospital will soon be able to surgically implant the first retinal prosthesis in the world that can partly restore a blind patient’s vision.

The company behind the Argus II Retinal Prosthesis System, Second Sight in Sylmar, Calif., said the idea for the technology was born at Duke.
The project began as “just a back porch idea,” according to Mark Humayun, a University of Southern California professor who received his education at Duke University Medical School and the University of North Carolina for biomedical engineering.
The Argus, which refers to the giant in Greek mythology with 100 eyes, is an innovation more than 20 years in the making.

The prosthesis includes an antenna, electronics case and electrode array that are surgically implanted in and on the eye. The external equipment includes glasses, a video processing unit and a cable.

The miniature video camera housed in the patient’s glasses captures a scene, which ends up being transmitted as instructions into the implant. Light patterns are created, which the patient learns to interpret as visual patterns, according to Second Sight.

The retinal prosthesis was approved by the U.S. Food and Drug Administration in February and will be implanted in patients suffering from severe to profound retinitis pigmentosa. These patients get diagnosed with the genetic disease in their 20s and slowly begin to lose their peripheral vision.

They’re “told they’re going to go completely blind in the next 20, 30 years,” said Robert Greenberg, Second Sight’s president and CEO. “It’s a completely devastating diagnosis. … For the longest time, these patients were told that there was nothing we could do.”

The best patient outcome they’ve documented so far has been the patient’s ability to read large letters. The majority of patients with the implant have been able to identify letters, Greenberg said.

The typical patient has their orientation and mobility restored, so they can figure out where they are in a room or can follow a line in a crosswalk.

One in 3,000 Americans suffer from retinitis pigmentosa. About 100,000 Americans total have it, but only 10,000 will be eligible for the implant, according to Dr. Paul Hahn, a Duke University Hospital ophthalmologist who will be responsible for the surgical implantation.

After the prosthesis was approved by the FDA, more than 100 retinal surgeons and more than 1,000 patients contacted Second Sight, and the company visited Duke this summer to examine the hospital and its key players. The hospital was approved as one of 12 test sites at the end of June.

“I think it’s something that’s going to change the way we think about vision and the way we practice,” Hahn said.

After the surgery, patients would require 10 to 15 hours of device programming and essentially relearn how to see. They will work with an occupational therapist to learn how to translate their new vision, he said.

Duke’s goal is to implant five devices within the first year. But the devices cost between $140,000 and $150,000, which means Hahn is looking at internal and external fundraising opportunities. The hospital also is waiting for insurance companies to recognize this procedure.

Greenberg received his undergrad education at Duke in biomedical engineering and electrical engineering, and he said the first patent for the Argus was assigned to Duke University more than 20 years ago. Since then, the technology has involved more than 200 issued patents and a couple hundred pending patents.

“It’s kind of nice to have this all come full-circle now,” he said.

When Greenberg attended Johns Hopkins University for his first year of medical school, he was inside the operating room when they tested the very first retinal prosthesis on a patient. Electrical currents ran through wires in one of the patient’s eyes, and the patient could see light.

“At that moment, I knew it would be possible,” Greenberg said.

In the future, Greenberg said he hopes the technology will restore vision for all cases of blindness. Their research breakthroughs in the lab right now has led them to produce color vision and to increase resolution, which he says will work like iPhone software updates to the retinal prosthesis.