Frequently asked questions
What is a clinical study?
A clinical study is research with human participants. Its goal is to address specific questions on a new treatment (for example medical device, vaccine, new therapies, or new indication for known treatment). Such a study allows to determine the safety and/or efficacy profile of a new medical technology or treatment in general.
What is PRIMA study?
PRIMA-US-FS study (clinical study in USA) is a feasibility clinical research study to evaluate the PRIMA bionic vision system, parallel to a similar feasibility study in France (PRIMA-FS) which successfully completed implantations in 5 patients. The first results from the study in France were reported during the American Academy of Ophthalmology AAO annual meeting held in Chicago in October 2018 and interim 6 months follow-up results were announced by the company in January 2018.
PRIMA is an active implantable medical device, intended for use as compensation of blindness for patients with Advanced Atrophic Dry Age-Related Macular Degeneration (dry-AMD).
How does PRIMA system work?
The PRIMA system aims to elicit useful prosthetic bionic vision by electrical stimulation of the retina and therefore partially compensating the loss of natural central vision. For more information about PRIMA system please click here.
Who is concerned, and how many patients will participate in the studies?
Two separate clinical studies (one in France and the other in USA) are being conducted for people with advanced atrophic dry age-related macular degeneration, with profound central vision loss. All planned 5 patients have already been successfully implanted for the European feasibility study being conducted in France. Recruitment for the separate feasibility clinical research study in USA is fully active, where total of 5 patients will be enrolled. For more information about both studies please refer to the clinical trial section.
What are the criteria to participate in the study?
· 60 years or older
· Visual Acuity of 20/400 (LogMAR 1.3) or worse (beyond legal blindness)
· No foveal perception
details about inclusion and exclusion criteria for the study being conducted in
USA please refer to the clinicaltrials.gov link for the
study description or contact the
participating center, the UPMC Eye Hospital tel: 412 647 3434 or email the UPMC Eye center.
What is the purpose of the studies, how can I benefit?
The objective for the feasibilitiy studies is to assess safety and elicitation of visual perception by electrical stimulation of the central retina with the PRIMA system. The PRIMA wireless photovoltaic subretinal microchip under investigation has already been implanted successfully in five patients in France, enabling elicitation of light perception in all 5 implanted subjects.
For these patients who no longer had natural central vision, combined with training and reeducation, PRIMA enabled majority of them to begin to correctly identify patterns, numbers and letters. The implanted microchip is well tolerated, with no device-related serious adverse events. The achieved prosthetic visual acuity to date is the best among those published from current artificial vision technologies. More details about the 6 months follow-up results from the study in France are available here.
If you are
interested in the clinical research study being conducted in the US, please
contact the UPMC EYE CENTER Pittsburgh PA, to request an appointment by calling
the following number: 412 647 3434 or by email by clicking here
What are the possible risks or side effects?
The procedures and study protocol include a list of known risks. They will be discussed with you by the study doctor and will also be detailed in the patient consent form.
Where does the study take place and with whom?
will take place at the UPMC Eye Center in Pittsburgh PA, with the principal
investigator Joseph Martel, MD. Tel: 412 647 3434 or email the participating center by clicking here
How long does the study take and how often should I expect to visit the clinic?
Study follow-up after implantation lasts up to 36 months. In addition to personalized training and reeducation program, the medical follow-up exams will be performed after 1 day, then 1 week, 6 weeks, and then 3, 6, 12, 18, 24 and 36 months after implantation.
Will my expenses and travelling to the site be covered?
By participating in the research study, the clinical research related expenses, including accommodation, transport and food during the study will be covered. All these expenses will be covered, whatever are the results of the study.
How will my personal data confidentiality be guaranteed?
The information related to you which will be used outside of the hospital, will not mention your name, date of birth or your contact details, or any information that would identify you.
Can I withdraw from the study?
Your participation in the research study is voluntary. You can choose to withdraw from the study at any time. There will be no penalty or loss of eligible expenses for the period covering your study participation, if you decide to not continue participating in the study.
Contact for Further Information
Further questions concerning this clinical feasibility study will be answered by the study doctor or trial coordinator at the participating site. They will be glad to answer any questions you might have about your rights as a participant in the present clinical research study.
Thank you for your interest in the PRIMA Study.
Please contact the participating
hospital if you have further questions or call 412 647 3434