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HomeminewsPositive New Bionic Eye Trial Results

Positive New Bionic Eye Trial Results

Associate Professor Penny Allen

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.1

Findings from the trial, led by the Centre for Eye Research Australia, Bionics Institute, University of Melbourne, and Royal Victorian Eye and Ear Hospital, add to interim results that showed that the second-generation bionic eye developed by Australian company Bionic Vision Technologies provided rapid improvements for four patients with blindness caused by 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.

… the device is stable and durable over the longer-term, staying in place behind the retina without complication and still having 97% of electrodes functioning 2.7 years after first implant

“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,” said Professor James Fallon, Head of Research at the Bionics Institute.

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% 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.”

Assoc Prof 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.”

The 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.

Outcomes from the clinical trial were published in Ophthalmology Science.2

References

  1. Bionic Vision Technologies, Bionic eye trial reveals substantial vision improvements over two and a half years (media release, 7 June 2024). Available at: bionicvis.com/news.
  2. Petoe, M.A., Abbott, C.J., Young, K.A., et al., A second-generation (44-channel) suprachoroidal retinal prosthesis: A single-arm clinical trial of feasibility, Ophthalmology Science, 2024 May 28. DOI: 10.1016/j.xops.2024.100525.