European and US regulators have approved a retinal implant and camera equipped glasses to improve irreversible blindness

Good news!

When can I get my eagle eyes and fine print reader? 😊

As an aside, in German prima means great!

"... retinal implant, which combines a tiny chip inserted beneath the retina with camera-equipped glasses to restore functional vision"

"“Science Corporation, a startup developing novel brain-computer interfaces (BCI), won approval from Europe’s medical device regulator to begin selling a device that restores vision lost from age-related macular degeneration.

The company said the device, called PRIMA, also received a designation from the US Food and Drug Administration that is the first step toward an expedited regulatory review, which could see the device used to treat two rare kinds of blindness.”"

From the abstract:

"Background

Geographic atrophy (GA) due to age-related macular degeneration (AMD) is the leading cause of irreversible blindness and affects over 5 million people globally. Currently, no therapies exist to restore vision to the affected persons. The PRIMA system combines a subretinal photovoltaic implant and near-infrared light-projecting glasses to restore sight to areas of central retinal atrophy.

Methods

In an open-label, baseline-controlled, multicenter, prospective, single-arm clinical study, the vision of participants with GA and a visual acuity of logMAR ≥1.2 was assessed with and without PRIMA glasses at six and twelve months.

The primary endpoints were the proportion of participants with improvement in visual acuity (VA) of logMAR 0.2 or more and the number and severity of study-related serious adverse events at 12 months.

Results

Thirty-two of thirty-eight enrolled participants reached the 12-month endpoint. Of the six who did not, three died, one withdrew, and two were unavailable for testing. Twenty-six (81.3%; 95% CI: 63.56–92.79%) had an improved prosthetic VA of at least logMAR 0.2 versus baseline (p<0.001) and

in 19 participants, there were 26 serious adverse events. Twenty-one of these events (81%) occurred within the first two months, of which 20 (95%) were resolved within two months of implantation. There was no significant change in peripheral natural VA compared to baseline.

Conclusions

In this study of a limited number of participants, the PRIMA system restored central vision with significant improvements of VA in participants with GA due to AMD. ..."

Doomslayer: Progress Roundup - by Malcolm Cochran

Science Corporation’s Vision-Restoring Chip Wins EU Approval

Science Corp. Announces European Commercial Launch of PRIMA, the Only Treatment to Restore Functional Central Vision to Patients with Geographic Atrophy Caused by Age-Related Macular Degeneration, a Leading Cause of Blindness (original news release)

Science Corporation PRIMA

Vision Restoration with the PRIMA System in Geographic Atrophy Due to AMD (open access)

The glasses

The implant

Figure 1. Rendering of the PRIMA system components.

Connecting the dots to artificially restore vision

Good news! The day is approaching when the blind can see again!

"A team of researchers from the Ecole Polytechnique Federale de Lausanne has developed a retinal implant that transposes images acquired by camera-equipped smart glasses into a simplified, black and white image made from 10,500 pixels. Although it has not been approved for human trial yet, the team has tested the implant in both a mouse model and a dedicated virtual reality programme, reporting the findings in Communications Materials.

For many patients suffering from retinitis pigmentosa – an inherited disease where progressive loss of retinal photoreceptors eventually leads to blindness – current retinal implants do not provide clear benefits. In fact, three years after surgery, most patients have stopped using them. ..."

"Retinal prostheses hold the promise of restoring vision in totally blind people. However, a decade of clinical trials highlighted quantitative limitations hampering the possibility of reaching this goal. A key challenge in retinal stimulation is to independently activate retinal neurons over a large portion of the subject’s visual field. ...
Here, we propose a wide-field curved organic photovoltaic epiretinal prosthesis with a high pixel density to address the aforementioned limitations. The high-density POLYRETINA implant was conceived to offer a large visual angle requiring minimal head scanning and a high resolution through epiretinal network-mediated stimulation, thus overcoming the nerve fibre’s direct activation. However, a high pixel density of the prosthesis does not necessarily correlate with high visual discrimination since the response resolution at the retinal ganglion cell (RGC) level might be altered by the high spatial interconnectivity of the retinal network ... Therefore, we investigated ex vivo the response resolution provided by this high-density retinal prosthesis. Our results demonstrated that POLYRETINA could achieve a high spatial resolution in epiretinal stimulation, which is a substantial step forward for artificial vision."

Connecting the dots to artificially restore vision – Physics World

Here is the link to the underlying research article:

Photovoltaic retinal prosthesis restores high-resolution responses to single-pixel stimulation in blind retinas (open access)