Oct 1 2014
Bionic Vision Australia (BVA), a consortium of researchers working together to develop bionic eye devices to restore a sense of vision to people with profound vision loss, today announced the successful completion of the first clinical trial of its prototype 24-channel percutaneous implant in patients with profound vision loss from the eye disease retinitis pigmentosa (RP). RP is an inherited, degenerative eye disease that causes severe vision impairment and often blindness through progressive degeneration of the retina and death of the photoreceptors.
The two year Prototype 24-Channel Percutaneous Connector Study, which started in May 2012, involved three RP patients with profound vision loss (bare light perception only) who each received surgically-implanted suprachoroidal electrode implants to aid the restoration of vision. Surgery was completed without any adverse events.
During the two year study, the implants were remarkably stable, with no significant movement, and were shown to be safe with no unexpected device-related serious adverse events observed. Although this was designed to be primarily a proof-of-concept and safety study, the trial also generated efficacy data showing that the device improved patient’s ability to see light and shapes, and helped with navigation around obstacles and detection of items on a tabletop search task.
“This study is critically important to the continuation of our research efforts and the results exceeded all our expectations,” Professor Mark Hargreaves, Chair of the BVA board, commented. “We have demonstrated clearly that our suprachoroidal implants are safe to insert surgically and cause no adverse events once in place. Significantly, we have also been able to observe that our device prototype was able to evoke meaningful visual perception in patients with profound visual loss.”
With this study complete, BVA has three other programs underway. The first of these, a 44-channel device will enter the clinic in mid-2015. The consortium is also developing a 98-channel device and a high acuity device.
BVA will be available to discuss this study at the AdvaMed2014 conference in Chicago on 6-8 October.