20 February, 2025
Image is courtesy of Anna Carlile
Summary
Advancements in retinal prosthesis technology, also commonly known as the bionic eye, have shown promising potential for individuals with advanced retinal diseases, particularly retinitis pigmentosa (RP). A recent clinical trial assessing the effectiveness of the Bionic Vision Technologies Second-Generation Suprachoroidal Retinal Prosthesis have provided valuable insights into both the functionality and safety of the device. The trial which focused on assessing the device’s ability to restore functional vision and improve quality of life, represents a significant step forward in vision restoration.
Two key research reports from the trial have recently been published, and delve into the feasibility, safety, and long-term impacts of this innovative device.
- A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: A Single-Arm Clinical Trial of Feasibility, (M.Petoe et al 2025) highlights the outcomes of a feasibility study that evaluated the device’s ability to enhance functional vision in four participants with advanced RP.
- Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Surgical Stability and Safety During a 2-Year Clinical Trial, (P.Allen et al 2025) provides an in-depth look at the surgical procedures, device stability, and safety profile of the implant.
Together, these studies underscore the potential of the Suprachoroidal Retinal Prosthesis to not only improve vision but also provide greater independence and enhanced quality of life for individuals living with severe vision loss.
Based on the success of this initial trial of Australia’s “second generation” bionic eye, the next step would be to obtain approval from the regulatory body in the US, the Food and Drug Administration (FDA). A multi-centre trial is however essential to gather sufficient data from more participants for FDA approval. FDA approval would precede an application to the Therapeutics Goods Administration (TGA) in Australia.
Progress Report: Second-Generation Suprachoroidal Retinal Prosthesis
The Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis has shown encouraging results in this clinical trial designed to test its safety, stability, and effectiveness for people with advanced retinitis pigmentosa (RP). The goal of the trial was to assess how well the device works in providing functional vision and improving the quality of life for those with limited or no vision.
Study Highlights
- Participants: Four individuals with advanced RP, who had very limited vision, received the implant in their worse-seeing eye. The study followed them for around 2.7 years to monitor how well the device worked and any potential side effects.
- Vision Improvements: All participants experienced improvements in tasks like locating objects, identifying movement, and navigating their surroundings. Some were even able to recognise objects and detect people, which helped them safely move around and explore new environments.
- Quality of Life: The implant had a positive effect on the daily lives of participants, helping them feel more confident and independent. Emotional well-being was maintained, and participants reported a better overall experience in daily activities.
- Device Stability: The device worked well over time, with almost all of the electrodes staying functional. There was minimal movement of the implant, indicating that the device stayed in place and continued to perform as expected.
Surgical and Safety Outcomes
- Surgery: The procedures to implant the device were successful and without complications. Recovery was smooth, and there were no serious side effects. Mild issues, like slight swelling or retinal haemorrhage, were short-lived and did not cause long-term problems.
- Functionality: The implant continued to work as intended, with only a small reduction in performance over time. The device allowed participants to use it successfully in their home environment, further improving their ability to do everyday tasks.
- Eye Health: The health of the retina and surrounding areas remained stable, with only minor changes due to the underlying condition of RP. The distance between the device and retina changed slightly but stabilised after about a year.
Conclusion
In this trial, the retinal prosthesis proved to be both safe and effective for people with advanced RP, offering improvements in vision and quality of life. The surgery was straightforward, and the device performed well over an extended period. These results suggest that the “second generation” bionic eye could be a promising option for individuals with advanced RP in the future, with potential for wider studies and eventual commercialisation.
Next steps
Resulting from the success of the initial trial, the team has achieved FDA breakthrough recognition but will require a multi-centre trial with data from more than 20 patients to obtain FDA approval. This new trial is expected to be conducted both in the U.S. and Australia.
Retina Australia’s support to the development of the Bionic Eye project
In 2022, Retina Australia awarded a research grant to Associate Professor Penelope Allen and team for the project, Improving real-world mobility and assessing long-term safety outcomes with a retinal prosthesis (“Bionic Eye”).
The project assessed the usefulness of a Depth Algorithm in relation to the “second generation” bionic eye, to help participants get a better idea of how close objects are. The study showed that the depth algorithm developed particularly helped users detect low contrast objects and reduced the false detection of shadows when outdoors when compared to our original algorithm, to improve the overall reliability of the device in different settings.
This work was presented at ARVO in 2023: https://iovs.arvojournals.org/article.aspx?articleid=2789031 as well as at the RANZCO Congress 2024, and is currently under peer review for a journal publication.
