The Retina Foundation of the Southwest is currently recruiting patients for a clinical trial of the Argus II Retinal Prosthesis, designed and manufactured by Second Sight Medical Products. If you are interested in participating in the study and believe that you may be eligible to participate in the trial, please contact Dr. David Birch, dbirch@retinafoundation.org, or Dr. Eugene Filley, efilley@retinafoundation.org. The Retina Foundation is one of several clinical trial sites in the United States, Mexico and Europe involved in this clinical trial.
Frequently Asked Questions about the Argus II research study.
Q: Am I a candidate for the Argus™ II system and study?
A: Patients eligible for consideration in this study are those who:
- have a confirmed history of retinitis pigmentosa with remaining visual acuity of light perception.
- have functional ganglion cells and optic nerve as determined by documented light perception or a measurable electrically evoked response.
- are at least 25 years or older.
- have a history of prior useful form vision in the worse-seeing eye.
- are willing and able to comply with the protocol and extensive follow-up visits.
- live within two hours drive by car from the Retina Foundation.
Subjects with optic nerve disease, glaucoma, diabetic retinopathy, ocular trauma, or a history of retinal detachment are not suitable candidates for this study. Subjects must also be physically able to undergo general anesthesia. Additional exclusion criteria will be explained to you by the clinician performing the study.
If you meet the inclusion and exclusion criteria described above, you may be a candidate. You would need to undergo a complete evaluation by the clinician performing the study to determine if you are a candidate.
Q: How does the device work?
A: The device consists of a tiny camera and transmitter mounted in sunglasses, an implanted receiver, and an electrode-studded array that is secured to the back of the eye by a micro-tack. A video processor and battery pack worn on the belt powers the entire device. The camera on the glasses captures an image and sends the information to the video processor, which converts the image to an electronic signal and sends it to the transmitter on the sunglasses. The implanted receiver wirelessly receives this data and sends the signals through a tiny cable to the electrode array, stimulating it to emit electrical pulses. The pulses induce responses in the retina that travel through the optic nerve to the brain, which perceives patterns of light and dark spots corresponding to the electrodes stimulated.
Q: How long will it work?
A: We cannot yet conclusively state what the expected lifetime of the implant is. Second Sight has undertaken extensive verification testing that indicates that the device should last many years, but the final determination on expected lifetime has yet to be made.
Q: How big is the implant? Will it be visible from outside?
A: There is a portion of the implant that sits on the outside of the eye, underneath the conjunctiva (the white-pink tissue around your cornea). Because it is covered by the tissue this portion of the device is not visible, although the bump that it creates under the tissue may be visible in some subjects. There is another small part of the device that goes into the eye and gets attached to the retina with a micro-tack. None of this portion would be visible to someone looking at the subject, although a physician will certainly be able to see this part of the device inside the eye when performing a routine eye exam.
Q: What else does the subject wear and what does it look like?
A: There are several external pieces that the subject has to wear. The most noticeable are the glasses which house the small camera and transmitting antenna. These glasses are dark and stylish. There is a cable that runs from these glasses to a processing unit that is about the size of a SONY Walkman®. The cable can run under clothing if desired and the processing unit can be held in the hand, attached to a belt or contained in a case or purse.
Q: Where is the study being performed?
A: This study is being performed at several sites across the United States, Mexico and Europe. Please check (http://clinicaltrials.gov/ct/show/NCT00407602 ) for the most up-to-date list of participating sites.
Q: Do I have to pay to be in the study?
A: Neither you nor your insurance company will have to pay for any procedures related to the study. You will not, however, be paid for your participation in the clinical study.
Q: How long does the trial go for?
A: The follow-up period for the study is three years from the date of implant. At the end of that time, you may be asked to participate in optional extended follow-up.
Q: What is the burden/ what do I have to do if I am in the trial?
A: To participate in the study you would have to undergo a series of tests prior to enrollment in the study to make sure you are a good candidate for the device. If you are enrolled in the study, you would undergo a surgery to have the device implanted. Following implantation, you would participate in the study for 3 years. During this time, you will have periodic clinical examinations and up to weekly testing with the device. The full details of study will be described to you by the clinician performing the study.
Q: Does having the device interfere with other aspects of my life? Can I still do all the activities I did before?
A: Participating in the study will not impose restrictions on what subjects can do. We do however, caution subjects not to rely on the system as their only means of mobility.
Q: Can I still go on vacation?
A: Yes. Although we ask participants to come in for testing regularly, arrangements can be made to miss testing sessions for any reason.
Q: What will the device allow me to see?
A: We do not know exactly how much you will see using the device. It is unlikely that the device will provide sufficient vision to recognize faces or read. Data presented at ASRS in October of 2008 indicated that the device provided significant improvements in orientation and mobility tests (finding doorways and following lines).
Q: Is the device proven to be safe?
A: The device has not yet been proven safe in humans. One of the purposes of the clinical study is to see if the device is safe.
Q: Can I/ Will I be implanted in both eyes?
A: In the study, we will be implanting only one eye. Your other eye will remain as is.
Q: I have more questions – whom should I contact?
A: If you are a prospective patient or are representing a prospective patient living within 2 hours of the Retina Foundation of the Southwest, please contact Dr. David Birch, dbirch@retinafoundation.org, or Dr. Eugene Filley, efilley@retinafoundation.org. Others may contact patients@2-sight.com or 1-818-833-5027 for more information.
CAUTION: Investigational device. Limited by United States Law to Investigational Use Only
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