The international, multi-center clinical trial was co-led by José-Alain Sahel, M.D., director of the UPMC Vision Institute; Daniel Palanker, Ph.D., professor of ophthalmology at Stanford University; and Frank Holz, M.D., professor of ophthalmology at the University of Bonn, Germany.

Clinical Trial Shows Significant Vision Gains

Among the 32 participants who completed one year of follow-up, 26 (81%) experienced meaningful improvements in visual acuity. In addition, 27 participants (84%) said they were using the artificial vision provided by the device at home to read numbers or words.

On average, patients gained 25 letters on a standard eye chart, equal to about five lines, when using the implant. Overall, 81% of participants improved by at least 10 letters.

“It’s the first time that any attempt at vision restoration has achieved such results in a large number of patients,” said Sahel, senior author of the study and chair of the Department of Ophthalmology at the University of Pittsburgh School of Medicine. “More than 80% of the patients were able to read letters and words, and some of them are reading pages in a book. This is really something we couldn’t have dreamt of when we started on this journey, together with Daniel Palanker, 15 years ago.”

How the PRIMA Retinal Implant Works

As AMD advances, the central field of vision becomes blurred because the retina’s light-sensing cells are permanently damaged. In a healthy eye, these photoreceptors capture light and convert it into electrical signals. Those signals travel through nerve cells at the back of the eye and then through the optic nerve to the brain, where images are formed.

The PRIMA system, originally developed by Palanker, is designed to replace damaged photoreceptors with a 2×2 mm wireless implant. The device converts light into electrical signals that stimulate surviving retinal cells. A camera built into specialized glasses records images and sends them to the implant using invisible near-infrared light. The implant then transforms that light into electrical pulses, helping restore the transmission of visual information to the brain. Users can adjust zoom and contrast settings to improve how clearly they see.

International Study Across Europe

The PRIMAvera trial enrolled 38 participants age 60 and older at 17 medical centers in five European countries: France, Germany, Italy, the Netherlands and the United Kingdom.

After 12 months of use, all side effects related to the procedure had resolved. Most participants demonstrated clear improvement in their ability to identify letters on an eye chart. One individual improved by 59 letters, equal to 12 lines.

“While we can’t yet restore full 20/20 vision with the implant alone, at UPMC we are investigating methods that could further improve people’s quality of life and take them above the threshold for legal blindness,” Sahel said.

Regulatory Steps and Ongoing Research

Following these results, the device manufacturer, Science Corporation, has submitted applications seeking approval for clinical use in Europe and the United States. UPMC became the first U.S. center to implant the PRIMA device in 2020 in a study led by associate professor of ophthalmology Joseph Martel, M.D.

Additional researchers involved in the study represent The University of Bonn; The Adolphe de Rothschild Foundation Hospital and The 15-20 National Eye Hospital, Paris; Moorfields Eye Hospital, London; and University of Rome Tor Vergata, among others.

The study was funded by Science Corporation, Alameda, Calif., (previously Pixium Vision SA, Paris, France).