- PRIMAvera trial with 38 participants at 17 centers in five countries: 27 of 32 returned to reading and 26 showed clinical acuity improvement.
- PRIMA System: 2x2 mm wireless photovoltaic microchip that uses infrared light with glasses and a processor to stimulate the retina.
- Safety: Adverse events were anticipated and mostly resolved, with no reduction in existing peripheral vision.
- Science Corporation has applied for authorization in Europe and the U.S.; resolution and software improvements are under development.
An international clinical trial has shown that a wireless retinal implant combined with glasses It can restore reading ability to people with central vision loss due to geographic atrophy., the advanced form of the age-related macular degeneration (AMD)The data, published in The New England Journal of Medicine, point to a functional improvement that until recently seemed unattainable.
More of the half of those who completed one year of follow-up They regained the ability to identify letters, numbers and words with the treated eye, and a large majority reported using the system in their daily lives for tasks as common as read mail or a leafletIt's not a cure, but it is a notable leap in autonomy.
What problem does it address and who participated?
Geographic atrophy (GA) It is the atrophic variant of AMD and the main cause of irreversible blindness in older adults; affects more than five million people worldwide. As it progresses, the Central vision is degraded by the death of the photoreceptors in the macula, while peripheral vision is usually preserved.
The PRIMAvera essay included 38 patients aged 60 years or older in 17 centers in five European countries (France, Germany, Italy, the Netherlands and the United Kingdom). Of the 32 who completed 12 months of follow-up, 27 were able to read again with the device and 26 (81%) achieved a clinically significant improvement in visual acuity.
Among the participants, there were particularly notable cases of improvement: one patient reached recognize 59 additional letters (12 lines) on the eye chart, and on average the gain was about 25 lyrics (five lines). In addition, the 84% reported using prosthetic vision at home to perform everyday tasks.
The study was co-directed by José-Alain Sahel (University of Pittsburgh), Daniel Palanker (Stanford University) y Frank Holz (University of Bonn), with the participation of teams such as Moorfields Eye Hospital of London and associated centers in France and Italy.
How the PRIMA system works
The device replaces damaged photoreceptors using a 2x2 mm, ~30 μm thick subretinal photovoltaic microchip that transforms light into electrical impulses to stimulate remaining retinal cellsIt does not have a battery: it is powered by the light it receives.
The set is complemented by a pair of glasses with a camera that capture the scene and project it onto near-infrared light over the implant. This projection prevents interference with any remaining natural vision and allows for adjustment zoom and contrast to make the fine details needed for reading more useful.
In the current configuration, the implant has a 378 pixel/electrode array that generates a black and white prosthetic vision. Researchers are working on new versions with higher resolution and software improvements to facilitate tasks such as facial recognition.
Clinical outcomes and rehabilitation
Analysis shows that, when using the system, participants substantially improved their performance on standardized reading tests. Even those who started out with a complete inability to identify larger letters several lines advanced after training.
The implantation is performed through ophthalmological surgery that usually lasts less than two hoursApproximately one month later the device is activated and a phase of intensive rehabilitation, crucial for learning to interpret the signal and stabilize your gaze with the glasses.
A relevant aspect is that the system does not reduce existing peripheral vision. The new central information provided by the implant integrates with natural side vision, which opens the door to combining both to daily life tasks.
Safety, adverse effects and current limits
As with any eye surgery, the following were recorded: anticipated adverse events (e.g., transient ocular hypertension, small subretinal hemorrhages, or localized detachments). The vast majority It was resolved in weeks With medical management, they were considered resolved after 12 months.
Today, the prosthetic vision is monochrome and with limited resolution, so it is no substitute for 20/20 vision. However, the ability to read labels, signs or headlines represents a tangible change in independence and well-being for people with AG.
Availability and next steps
Based on the results, the manufacturer, Science Corporation, has requested regulatory authorization in Europe and the United States. Several teams—including Stanford and Pittsburgh—are exploring new improvements hardware and algorithms to enhance sharpness, expand grayscale, and optimize performance in natural scenes.
Outside of rehearsals, the device not available yet in clinical practiceIf approved, its adoption is expected to be gradual and focused, initially, on patients with geographic atrophy who meet selection criteria and are willing to do the necessary training.
The published results reflect solid progress: more than 80% of patients tested were able to read letters and words using prosthetic vision without sacrificing peripheral visionThere is still a long way to go—improving resolution, comfort, and facial recognition—but the leap forward made by subretinal retinal implants marks a turning point for those who had lost their reading due to AMD.
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