Results of the first clinical trial of Australia’s ‘second generation’ bionic eye have demonstrated ‘substantial improvement’ in four participants’ functional vision, daily activities and quality of life over a period of more than two and a half years.
Detailed outcomes from the trial, led by the Centre for Eye Research Australia, Bionics Institute, University of Melbourne and Royal Victorian Eye and Ear Hospital, are published in Ophthalmology Science.
The findings add to interim results which showed that the second-generation bionic eye developed by Australian company Bionic Vision Technologies provided rapid improvements for four patients with blindness caused the genetic eye condition retinitis pigmentosa.
Retinitis pigmentosa is an inherited retinal disease which affects about two million people worldwide and is one of the leading causes of vision loss in working-age people.
The bionic eye comprises an electrode array, designed by the Bionics Institute and the Centre for Eye Research Australia, that is surgically implanted behind the eye. The electrode receives signals from a video camera mounted on glasses, which stimulate the patient’s retina.
Professor James Fallon, Head of Research at the Bionics Institute said: “The camera converts images into electrical pulses delivered by the electrode array that activate retinal cells and create flashes of light called phosphenes to help patients detect edges, shapes and movement.’’
The new study tracked the patients from the time they received the implant surgery in 2018 to 2021. Its findings demonstrate the device is stable and durable over the longer term– staying in place behind the retina without complication and still having 97 per cent of electrodes functioning 2.7 years after first implant.
Principal Investigator and vitreo-retinal surgeon Associate Professor Penny Allen said patients showed significant improvement in their navigation, mobility and ability to detect objects – in clinical tests, at home and in the community.
“The bionic eye enabled blind patients to locate doorways, avoid obstacles and find items on table-tops,’’ she said. “They reported greater confidence in navigation, were more likely to explore new environments and had reduced need for assistance when travelling to the local shops.’’
Associate Professor Allen said participants reported that the bionic eye supplemented long cane and guide dog use, provided safe navigation around people and obstacles, and allowed them to detect waypoints such as trees and lamp posts along navigational routes.“Patients were also able to locate their spouse in a café and detect people moving at a train station – things they could not do without using their bionic eye.’’
Bionic Vision Technologies’ team is continuing to refine the vision processing capabilities, usability, as well as the wearables of the bionic eye system.
Dr Ash Attia, CEO of Bionic Vision Technologies said: “ We are encouraged by the excellent results of the generation 2 Bionic eye trial. We are looking forward to finalise the development of the Generation 3 bionic eye and enter the worldwide pivotal trial and ultimately gain regulatory approval. Regulatory approval will allow us to make this important technology available to RP patients which will positively impact their lives” Dr Attia said.
Interviews: Associate Professor Penny Allen, Professor James Fallon and a bionic eye research project participant and Ash Attia from Bionic Vision Technologies are available for interview.
Video footage: Video footage of trial participants in action and phosphenes is available.
Read the study https://doi.org/10.1016/j.xops.2024.100525
Petoe, Matthew A., et al. "A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: A Single-Arm Clinical Trial of Feasibility." Ophthalmology Science (2024): 100525.
Media contacts:
For Associate Professor Penny Allen and trial participants: Janine Sim-Jones, Centre for Eye Research Australia, jsimjones@cera.org.au, +61 420 886 511
For Professor James Fallon, Chief Technology Officer and Head of Research Operations, Breanna Smith, Bionics Institute , bsmith@bionicsinstitute.org, +61 499 399 510
For Bionic Vision Technologies Dr Ash Attia, Chief Executive Officer ash.attia@bionicvis.com, +61 419 691 229
About the Centre for Eye Research Australia The Centre for Eye Research Australia (CERA) is an independent medical research institute based at the Royal Victorian Eye and Ear Hospital in Melbourne and affiliated with the University of Melbourne. An international leader in eye research, we’re deeply committed to conducting research with real-life impact. Our goal is to prevent vision loss and blindness and, ultimately, find cures to restore sight.
About the Bionics Institute The Bionics Institute is an internationally recognised, independent medical research institute that solves medical challenges with technology. We lead the world in the research and development of innovative medical devices and therapies to transform the lives of people with hearing and vision impairment, autoimmune and chronic conditions, and conditions affecting the brain. For more information, go to: www.bionicsinstitute.org
Bionic Vision Technologies Bionic Vision Technologies Pty Ltd (BVT) is a privately owned ophthalmic research and development company dedicated to restoring functional vision to the visually impaired. The company is currently working on two main projects: an implantable bionic eye system for individuals severely affected by Retinitis pigmentosa, and a non-implantable device that helps blind users detect and navigate around objects using vibration. Both products have undergone clinical feasibility studies. The company is now seeking funding to complete further studies for regulatory approval and eventual commercialisation in global markets.
About us:
About the Centre for Eye Research Australia The Centre for Eye Research Australia (CERA) is an independent medical research institute based at the Royal Victorian Eye and Ear Hospital in Melbourne and affiliated with the University of Melbourne. An international leader in eye research, we’re deeply committed to conducting research with real-life impact. Our goal is to prevent vision loss and blindness and, ultimately, find cures to restore sight.
About the Bionics Institute The Bionics Institute is an internationally recognised, independent medical research institute that solves medical challenges with technology. We lead the world in the research and development of innovative medical devices and therapies to transform the lives of people with hearing and vision impairment, autoimmune and chronic conditions, and conditions affecting the brain. For more information, go to: www.bionicsinstitute.org
About Bionic Vision Technologies Bionic Vision Technologies Pty Ltd (BVT) is a privately owned ophthalmic research and development company dedicated to restoring functional vision to the visually impaired. The company is currently working on two main projects: an implantable bionic eye system for individuals severely affected by Retinitis pigmentosa, and a non-implantable device that helps blind users detect and navigate around objects using vibration. Both products have undergone clinical feasibility studies. The company is now seeking funding to complete further studies for regulatory approval and eventual commercialisation in global markets.
Contact details:
Janine Sim-Jones, Centre for Eye Research Australia, jsimjones@cera.org.au, +61 420 886 511
Breanna Smith, Bionics Institute , bsmith@bionicsinstitute.org, +61 499 399 510
ash.attia@bionicvis.com, +61 419 691 229