[blindza] Re: Fw: Microchips in the Eye

  • From: "Robin Barker" <robinb@xxxxxxxxxx>
  • To: <blindza@xxxxxxxxxxxxx>
  • Date: Thu, 3 Mar 2011 07:14:29 +0200

 Hi Jacob,
Thanks for the article.  Interesting and looking forward to the advances.
Robin

-----Original Message-----
From: blindza-bounce@xxxxxxxxxxxxx [mailto:blindza-bounce@xxxxxxxxxxxxx] On 
Behalf Of Jacob Kruger
Sent: Thursday, March 03, 2011 6:32 AM
To: NAPSA Blind
Cc: BlindZA
Subject: [blindza] Fw: Microchips in the Eye

----- Original Message -----
Microchips in the Eye.

Electronic retinal implants are gaining popularity as research into the 
technology continues to show improvements for patients.

About 30 research groups worldwide are currently working on an electronic 
retinal implant. Retina Implant AG, a company in Reutlingen, Germany, has 
conducted a successful clinical pilot study demonstrating that the technique of 
subretinal stimulation permits visual recognition of patterns and letters of 
the alphabet. This study confirms electronic retinal implants can give very 
useful visual perceptions to the blind (See three videos regarding Retina AG 
study results and demonstrations 
http://www.mddionline.com/video-vault-retina-implant-ag-electronic-microchip
 ).

Hereditary retinal degeneration (retinitis pigmentosa) results in a progressive 
loss of photoreceptors and in most cases leads gradually to a complete loss of 
vision. More than 100,000 people in the United States and an estimated three 
million people worldwide suffer from various forms of this disease. Although 
drugs are currently under development, there is as yet no therapy for this 
ailment. However, many of those affected may soon be able to recover a certain 
degree of vision by means of an implanted camera chip.

In the normal eye, incident light passes through the transparent tissue of the 
retina and falls on some 120 million rods and six million cones at the fundus 
of the eye. The light is converted in a multiple-stage process into electrical 
signals. These signals undergo preliminary processing in the underlying layers 
of bipolar, horizontal, and amacrine cells and are then passed on to the 
ganglion cells. For their part, the axons of the ganglion cells communicate 
with the optic nerve, which forwards the information gained thus far to the 
visual cortex (i.e., visual center) of the brain.

Subretinal Implants.

Diseases like retinitis pigmentosa (RP) are distinguished by the fact that a 
large part of the retina remains functional even after loss of sight. 
Although
the rods and cones that normally convert light into nerve signals are destroyed 
by this disease, most of the retinal nerve tissue, which has the task of 
pre-processing information on its way to the brain, remains intact. In other 
words, the visual apparatus is functional; it just lacks input. Based on this 
concept, Eberhart Zrenner at the University Eye Clinic of Tübingen has 
developed a subretinal implant in cooperation with that university's Institute 
of Natural Science and Medicine (NMI).

For the university's implant, natural optical stimulus is simply replaced by 
pulsed, light-dependent electrical stimuli, resulting in the perception of 
phosphenes (artificially triggered light phenomena). Because the electrical 
excitation invariably involves a number of cells, the patients cannot visualize 
objects sharply, but are nevertheless able to locate light sources and localize 
physical objects.

The implant is located subretinally, i.e. behind the retina. From an anatomical 
point of view, it exactly replaces the photoreceptors that have been lost (see 
Figure 1). From the viewpoint of signal processing, this is an all-important 
advantage; the implant's subretinal excitation exploits the full range of 
neuronal circuitry in the retina along the way to the optic nerve. The 
electrical signal is triggered at the point of brightness, and the stimulation 
strength corresponds to the intensity of the incident light. The optical image 
is thus exactly replaced by an electrical pattern of excitation.

The retinal implant consists of a silicon chip about 3 × 3 mm in size and 70-µm 
thick, with 1500 individual pixels. Each of these pixel cells contains a 
light-sensitive photodiode, a logarithmic differential amplifier, and a 50 × 
50-µm iridium electrode into which the electrical stimuli at the retina are 
guided. The circuitry was developed in collaboration with the IMS in Stuttgart 
and is made by applying 0.8-µm CMOS technology.2 The result is a pure analog 
chip, with the advantage that its power consumption is very low (maximum 10 
mW), and the heat passed on to the retina by electrical power from the chip 
remains below 0.5 K. The microchip is positioned on a thin, highly flexible 
circuit board of polyimide with gold circuits that transmit power and control 
signals (See Figure 2). The very fine polyimide strip is connected in turn to a 
thin, coiled cable through which the electricity of the chip is supplied. This 
elastic cable passes through the orbital cavity to the bone of the temple and 
from there to a point behind the ear, where it is connected to an inductive 
power supply unit in a ceramic housing. The electrical energy is received 
inductively from the outside through a second coil that is located on the skin. 
Permanent magnets in the two coils ensure close contact.

All of the components must of course be biocompatible-that is, well tolerated 
by the body-and must possess long-term stability. This is an enormous 
technological challenge that requires, among other things, the use and 
combination of new materials. The components must be provided with a 
hermetically sealed protective layer at the point of contact with the 
surrounding tissue. They must undergo numerous tests to demonstrate the 
device's ability to withstand the corrosive environment within the body. An 
especially critical point is that the presence of electrical voltage can 
greatly accelerate the corrosion process. The selection of materials and the 
manner in which they are processed is critical.

Above all, the electrodes and their contact points on the chip are of decisive 
importance. The useable electrode surface must be as small as possible but also 
offer as large a surface as possible to ensure good contact with the retina. 
For
this reason, the electrodes are manufactured of fractal iridium, whereby the 
materials permit a higher transmission of charges.
Optimal visual perception is present when pulse durations are around 1 
microsecond and the charge amounts to 2-5 nC per pixel. This corresponds to a 
voltage of up to 2 V. The repetition rate of excitation is normally 5-7 Hz, 
because higher rates would result in overstimulation of the retina. The 
patient's visual perception therefore flickers somewhat.

Clinical Studies and Results.

During a clinical pilot study at the University Eye Clinic in Tübingen, the 
retinal implant was first tested over a period of up to four months in 11 
patients. The development of a new type of surgical procedure was given high 
priority in collaboration with the University Eye Clinic in Regensburg, Germany.
It involves creating a small access opening through the external sclera of the 
eye. After removal of the vitreous, the retina is lifted up from its underlying 
support layer so that the flexible film with the chip can be advanced under the 
retina to the vicinity of the macula. This is the point at which density of the 
nerve cells is greatest and can be expected to result in the most effective 
stimulation. Following exact positioning, the small window through the sclera 
is again closed, thus attaching the film securely in the globe of the eye so 
that the chip can assume a stable position and is not subjected to tension due 
to movements of the eye.

It was already possible to conduct initial tests with the patients only one 
week after implantation. The majority of patients recognized not only 
horizontal and vertical lines but also the direction in which electrodes were 
activated one after another and simple geometric patterns. However, the 
threshold value for triggering a stimulus varied widely in the different 
patients. In some cases, it was possible to trigger a phosphene with individual 
electrodes and a charge transfer of only a few nanocoulombs. However, many of 
the patients experienced visual perception only when several.
adjacent electrodes were stimulated simultaneously.3 The causes of these 
patient-specific threshold values may be both the position of the electrodes 
relative to the macula and the distance between the electrodes and the bipolar 
cells in the retina.

Most of the patients reported blurred visual perception. Many were able to 
distinguish light sources or bright objects against a dark background. As the 
ability to recognize objects grew in each patient, it became possible to 
continuously optimize the stimulation parameters and the position of the chip 
in the eye so that three of the 11 patients were reliably able to recognize 
simple patterns when the chip was turned on and even bright objects against a 
dark background. In fact, the last test subject correctly recognized letters of 
the alphabet that measured ca. 8 cm high, was able to localize people in a 
room, and identified their size. A standard visual examination of this patient 
with Landolt C Rings resulted in a visual acuity of 1/50, which is slightly 
above the threshold of legally defined blindness (according to WHO). This was 
conclusive proof that the basic concept of the subretinal implants functions 
successfully and can lead to usable visual perception.4

The learning effects that the authors observed were noteworthy: the patients 
needed only a few hours to learn how to process visual perceptions that were 
new to them. One patient who had been completely blind for the last 15 years 
was able to see the letters of the alphabet, and told the investigator that the 
letters looked "exactly as I learned them at school." When his name was 
presented to him, he immediately recognized a spelling error in it. In 
addition, hand-eye coordination was also relearned within a few hours. The 
patients were able to localize physical objects precisely and point to them 
immediately.

Geometric patterns and physical objects from daily life were recognized, 
especially when they had very characteristic forms (such as a banana). They 
were also able to distinguish items of tableware (spoons, knives, forks) from 
one another.

Now that the pilot study is complete, the implant has become the subject of a 
multicentered main study with a larger patient set. The aim of the 
investigation is to gain regulatory approval for use as a medical product in 
1-2 years. 
After
it has been successfully used in retinitis pigmentosa patients, the plan is to 
test and apply the visual chip in patients with age-related macula degeneration
(AMD) as well.

Acknowledgements.

This research was supported by the German Federal Ministry of Education and 
Research, the Kerstan Foundation, and ProRetina Germany.

References.

    1. E Zrenner, "Will Retinal Implants Restore Vision?" Science 295, no. 
5597
(February 2002): 1022-1025.
    2. HG Graf et al., "High Dynamic Range CMOS Imager Technologies for 
Biomedical Applications," IEEE Journal of Solid-State Circuits 44, no. 1 
(January 2009):  281-289.
    3. E Zrenner, "Restoring Neuroretinal Function: New Potentials, Documenta 
Ophthalmologica (2007): 56-59.
    4. E Zrenner et al., "Subretinal Electronic Chips Allow Blind Patients to 
Read Letters and Combine Them to Words," Proceddings of the Royal Society, 
Biological Sciences, online (November 3, 2010): doi:10.1098/rspb.2010.1747.
    5. L Rothermel et al., "A CMOS Chip With Active Pixel Array and Specific 
Test Features for Subretinal Implantation" IEEE Journal of Solid-State Circuits 
44, no. 1 (January 2009): 290-300.

Walter-G. Wrobel, PhD, is president and CEO of Retina Implant AG. Alex 
Harscher, PhD, is vice president of operations at the company.


Source URL:
http://www.mddionline.com/article/microchips-eye

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