05.02.2023
Patient Summary
Post-traumatic abiotrophy of all layers of the retina OU including axons – atrophy of the optic nerve OU.
Right eye: irritated, multiple corneal scars with sutures, corneal clouding. The corneostellar graft covers the infiltrated part of the cornea. Deeper environments are not rendered. Dim reflex from the fundus of the eye.
Left eye: Subatrophy of the eyeball, the eye is moderately irritated, the corneal graft is correctly positioned, and the sutures are capable. Environments located deeper are not visualized. Dim reflex from the fundus of the eye.
Research Inquiry
The research report will contain the following information:
Solutions and systems in different stages of development in the field of cortical visual prostheses technologies.
Clinical trials and experimental systems that might be relevant according to the patient description.
Experts and contact relevant for consultation and trial enrollment.
Any other information that could benefit the patient in the present or future for vision restoration.
Research Findings
Over the last decades, technology has improved to the point that electronic devices may now be implanted into the visual pathway to restore some sight. Visual neural prostheses are a technique for creating a visual experience by stimulating the visual signal directly. The stimulation of early visual cortex regions produces optical illusions and is used to build cortical visual prostheses1.
Vivani (formerly Second Sight Medical)
General Description: Second Sight Medical Products develops and markets implantable visual prosthetics that are intended to deliver a useful artificial vision to blind individuals. A recognized global leader in neuromodulation devices for blindness, the Company is committed to developing new technologies to treat the broadest population of sight-impaired individuals. The Company’s headquarters are in Los Angeles, California.
Vivani is currently exploring strategic options for advancing Orion II, a follow-on candidate to the Orion® Visual Cortical Prosthesis System. This investigational device is intended to bring meaningful artificial vision to individuals who are profoundly blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, or forms of cancer and trauma.
Orion Visual Cortical Prothesis: Orion Visual Cortical Prosthesis System (Orion) is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light2.
Preliminary results and publications: In May 2021, Second Sight Medical Products announced two-year results of its Early Feasibility Study of the Orion Visual Cortical Prosthesis. The Study is a single-arm six-subject study at UCLA and Baylor College of Medicine. All subjects are still enrolled in the Study and recent visual function and functional vision results continue to demonstrate that a majority of participants benefit from Orion. Five out of five of those tested at the two-year mark are able to locate a white square on a dark computer screen significantly better with the Orion System on than with it off. Four out of five of those tested at the two-year mark are able to better identify the direction of motion of a bar moving across a computer screen with the Orion System on2.
Publications and results:
Dynamic Stimulation of Visual Cortex Produces Form Vision in Sighted and Blind Humans.
Sequence of visual cortex stimulation affects phosphene brightness in blind subjects.
Clinical Trials: Early Feasibility Study of the Orion Visual Cortical Prosthesis System (NCT03344848) – Active, not recruiting.
Location 1: University of California, Los Angeles, California, United States, 90025.
Location 2: Baylor College of Medicine, Houston, Texas, United States, 77030.
Study Director: Uday Patel, Ph.D. – upatel@secondsight.com
Contacts:
Uday Patel, Ph.D. – Director, Clinical and Scientific Affairs at Second Sight Medical Products.
Mail: upatel@secondsight.com
Michael Stephen Beauchamp, Ph.D. – Professor of Neurosurgery.
Mail: beaucha@upenn.edu
Michelle Armenta Salas – Biomedical engineer – research scientist, involved in clinical research in Blackrock Neurotech as part of Orion evaluation.
CORTIVIS
General Description: CORTIVIS is a European research collaboration made up of 6 university laboratories, 1 technical research organization, and 1 biomedical device company. Their headquarters are located in Alicante, Spain.
Technology Description: The whole system will use a bioinspired (retina-like) visual processing front-end, able to transform the visual world in front of a blind individual into electrical signals that can be used to excite, in real-time, the neurons at his/her visual cortex. The output information from this bioinspired peripheral device will be used to stimulate an array of penetrating electrodes implanted into the primary visual cortex. Such a visual neuroprosthesis is expected to recreate a limited, but useful visual sense in a blind individual who is using such a system6.
Preliminary results and publications: An early study in monkeys demonstrated that electrical stimulation of implanted electrodes elicited visual perception, and early investigations in human epilepsy or brain tumor patients were undertaken after brain surgery. Promising results were obtained based on the safe implantation, high-quality visual cortex recordings, and induced perception of phosphenes. A novel technology dubbed “The High-Channel-Count Neuroprosthesis” was recently tested on monkeys with successful outcomes. In this trial, a total of 1,024 electrodes were implanted in the geniculate receiving layer of the primary visual cortex (V1) and in the ventral visual stream region V4. The monkeys implanted with these devices demonstrated the ability to distinguish basic shapes, movements, and letters8.
First results from a clinical trial (NCT02983370) – A 96-electrode intracortical microelectrode array was implanted in the visual cortex of a 57-year-old man who was completely blind for 6 months. Single-unit recordings were achievable, and phosphene-eliciting stimulation thresholds were within acceptable limits and remained consistent throughout the trial. Simple kinds of spatially patterned electrical stimulation elicited discriminable patterned percepts, enabling the blind person to distinguish object borders and identify various letters. Researchers also observed a learning mechanism that enabled the individual to distinguish stimulus patterns over several presentations (see Figure 2). The short-term outcomes in a single patient are promising. However, further research with more people and over a longer period needs to be conducted to determine whether intracortical microelectrodes may offer a limited but functional experience of vision to the blind7.
Clinical Trials: Development of a Cortical Visual Neuroprosthesis for the Blind (CORTIVIS) – NCT02983370 – Active and recruiting.
Description: The investigators will implant the CORTIVIS vision neuroprosthetic system, which utilizes an FDA-cleared microelectrode array, into blind human volunteers and obtain descriptive feedback about visualized percepts. The experiments are designed to learn if volunteers can learn to integrate the electrical stimulation of brain visual areas into meaningful percepts. It is expected that a cortical device can create truly meaningful visual percepts that can be translated into functional gains such as the recognition, localization, and grasping of objects or skillful navigation in familiar and unfamiliar environments resulting in a substantial improvement in the standard of living of blind and visually impaired persons.
Location: Hospital IMED Elche – Elche, Alicante, Spain, 03202.
Contact: Eduardo Fernandez, MD and Ph.D. – Principal investigator.
Phone: +34965222001
Mail: e.fernandez@umh.es
Contacts:
Eduardo Fernandez, MD, Ph.D. -Neuroengineering Research group director at Universidad Miguel Hernandez de Elche.
Mail: e.fernandez@umh.es
Monash Vision Group (Gennaris)
General Description – The Monash Vision Group (MVG) is a joint venture involving Monash University, Grey Innovation, MiniFAB, and Alfred Health in Australia. MVG is developing the “Gennaris” bionic vision system, a cortical vision prosthesis. Since its inception in 2010, they have been working to develop a clinically viable bionic vision system, and to demonstrate the safety and usefulness of this system in a small number of recipients with complete, bilateral blindness8.
Technology Description (Gennaris): The core technology under development by Monash Vision Group involves a wireless implant that is designed to deliver patterned electrical stimulation to the brain. Up to 11 of these implants, each of which is around the size of a thumbnail, may be placed on the surface of the brain and programmed wirelessly to stimulate brain cells with tiny electrical pulses. These electrical pulses can be interpreted as visual information, providing the recipient with basic shapes and outlines that may assist with navigation, object recognition, and other basic everyday tasks9.
Preliminary results and publications: Ten arrays (7 active, 3 passive) were implanted in three sheep using a pneumatic inserter. Each device consisted of a wireless receiver and Application Specific Integrated Circuit encased in a ceramic box and could deliver electrical stimulation through one of 43 electrodes. Stimulation was delivered through seven of these devices for up to 3 months and each device was treated as independent for further analysis. Cumulatively, over 2700h of stimulation were achieved without any observable adverse health effects. Histology showed that the devices and implantation procedure were well tolerated by the brain with a similar tissue response to the more common Utah arrays. The results indicate that long-term stimulation through wireless arrays can be achieved without the induction of widespread tissue damage9.
Group publications:
CMOS stimulating chips capable of wirelessly driving 473 electrodes for a cortical vision prosthesis
Restoration of vision using wireless cortical implants: The Monash Vision Group project
Clinical Trials: No clinical trials are ongoing, after the described pre-clinical trials in sheep, the research team plans and hopes they will be able to start clinical trials in humans in five years (article written in august 2021). The progression to clinical trials also depends upon securing enough funding12
Contacts:
Project director – Professor Arthur Lowery – Department of Electrical and Computer Systems Engineering – Monash University.
Mail: Arthur.Lowery@monash.edu
Phone: +61 3 9905 3475
Address: Room 214, 16 Alliance Lane, Clayton Campus.
Jeffery Rosenfeld – Emeritus Professor of Surgery – Senior Neurosurgeon – The Alfred Hospital – Monash University.
Yan Wong – Associate Professor – Department of Electrical and Computer Systems Engineering – Monash University.
Mail: Yan.Wong@monash.edu
Phone: +61 3 9905 1935
Address: Room 220, 14 Alliance Lane, Clayton Campus
Marcello Rosa – Professor of Physiology – Monash Biomedicine Discovery Institute.
Mail: Marcello.Rosa@monash.edu
Ramsedh Rajan – Professor of Physiology – Monash Biomedicine Discovery Institute.
Phone: +61 3 9905 2525
Address: Wellington Road, 26 Innovation Walk 3800 Monash Australia.
Intracortical Visual Prosthesis Project (ICVP) – Illinois Institute of Technology
General Description: Illinois Institute of Technology (IIT) received a grant from the National Institute of Neurological Disorders and Stroke (NINDS), BRAIN Initiative to conduct an early feasibility study of an intracortical visual prothesis. The Intracortical Visual Prosthesis (ICVP) System is designed to bypass the retina and optic nerves by connecting directly to the visual cortex of the brain. The ICVP System is the first intracortical visual implant to use a group of fully implanted, miniaturized, wireless stimulators to help individuals with no sight to visualize rendered images in real-time.
Technology Description : 16 parylene-insulated iridium microelectrodes, a Wireless Floating Microelectrode Array (WFMA) was constructed and placed on the visual cortex surface, an integrated circuit microprocessor, and a microcoil with wireless power and activation. A video camera installed on eyeglasses or a headband communicates with the video processing unit, which translates pictures to a pattern that can be mapped to the array of electrodes. The signal is subsequently delivered to the head-mounted telemetry controller through the stimulation modules, which wirelessly distribute signals and power to each WFMA module8,13.
Preliminary results and publications: Animal studies in a 9.5 months period where the researchers implanted a WFMA into each of 6 rats’ left sciatic nerves and observed that a combination of wireless communication and a low-profile neural interface permitted very steady motor recruitment thresholds and fine motor control in the hind limb. The results of the study laid the ground for further development of visual prothesis14. Further preclinical trials in animals showed the feasibility of the approach and technology supporting the continuation to clinical trials in humans15. Next, during the preclinical phase, the Illinois Tech team worked with Rush University Medical Center neurosurgeons to develop and refine surgical procedures, culminating in the successful implantation of 25 stimulators with a total of 400 electrodes in an individual with blindness. The clinical phase is currently ongoing aimed at testing whether this prosthesis will provide study participants with an improved ability to navigate and perform basic, visually guided tasks16.
Group publications:
Clinical Trials: A Phase I Feasibility Study of an Intracortical Visual Prosthesis (ICVP) for People With Blindness (NCT04634383) – Active and recruiting.
Description: The objective of this study is to test the safety of the ICVP system and the feasibility of eliciting visual percepts in response to electrical stimulation in persons with blindness. The electrical stimulation is provided by wireless floating microelectrode arrays (WFMAs) that are part of the ICVP system. The WFMAs are implanted in the visual cortex. Five participants will take part in the study and each participant will have multiple WFMA devices implanted in their visual cortex on one side of the brain. After recovery from surgery, participants will begin a series of tests to assess the ability of electrical stimulation to induce visual percepts and how these percepts may provide some measure of artificial vision. Weekly participant testing will occur over a period of one to three years.
Location: Illinois Institute of Technology – Chicago, Illinois, United States, 60616.
Principal investigator and recruitment director: Philip R Troyk, Ph.D.
Mail: ICVP@iit.edu
Phone:+1 312-567-5304
Contacts:
Dr. Philip Troyk, Ph.D. – Principal investigator – Executive Director, Pritzker Institute of Biomedical Science and Engineering – Professor of Biomedical Engineering.
Mail: troyk@iit.edu , philip.troyk@iit.edu
Phone: +1 (312) 5676902
Dr. Frank Lane, Ph.D. – Co-Principal Investigator – Associate Chair & Associate Professor of Psychology,Illinois Institute of Technology
Mail: drflane@gmail.com , flane@iit.edu
Phone: +1 (312) 6086450
Meesa Royster – Assistant director of Low Vision Research – Director of Scientific and Clinical Initiatives at The Chicago Lighthouse.
Phone: +1 (312) 6661331
Patricia Grant, Ph.D. – Vice President of Research at The Chicago Lighthouse.
Phone: +1 (608) 8294500
References
