Frequently asked questions

What is a clinical study?

A clinical study is research on humans. 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 are PRIMA studies?

PRIMA FS study (European study), and PRIMA-US-FS study (American study) are both first in human feasibility studies to evaluate the PRIMA bionic vision system, which is an active implantable medical device, intended as compensation of blindness for patients with Advanced Atrophic Dry AMD, (Age Related Macular Degeneration).

How does PRIMA system work?

The PRIMA system aims to elicit functional artificial vision by electrical stimulation of the retina and therefore partially compensating the natural central vision loss. For more information about PRIMA please click here.

Who is concerned, and how many patients will participate in the study?

This study is intended for people with atrophic dry age related macular degeneration, with profound central vision loss. 5 patients will be enrolled for the European feasibility study and 5 patients for the American feasibility study. 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

· …

For more details about inclusion and exclusion criteria please refer to the clinicalGov link to the study.

What is the purpose of the study, how can I benefit?

The objective of the study is to assess elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates.

The device under investigation was never tested in humans before. Currently the benefit for the patient is not yet known. Data and simulations available so far suggest that the wireless implant system may potentially allow to visualize and locate light sources and, for example, recognize high contrast objects and large sized letters.

What are the possible risks or side effects?

The procedures and study protocol include known risks. They will be discussed with you by the study doctor and will also be detailed in the consent form.

Where does the study take place and with whom?

For more information about the participating centers and contacts please click here.

How long does the study take and how often should I visit the clinic?

Study follow-up after implantation lasts up to 36 months. 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 transmitted outside of the hospital, will not mention your name, date of birth or your address that would to 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 earnings 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 considering to participate in the PRIMA Study. Please contact your doctor or a health professional if you have further questions.