PRIMA US Feasibility Study: CLINICAL STUDY ADVANCED DRY AMD
Normal vision
Central vision loss with dry AMD
Get in Touch
If you are interested in participating in the study, contact Monique Nguyen, Clinical Research Coordinator Associate, by phone: (650)498-8790, or email: moniquenguyen92@stanford.edu
Participant's rights questions, contact:
1-866-680-2906
DEVICE MANUFACTURER
Pixium Vision
74 rue du Faubourg St Antoine,
75 012 Paris, France
www.pixium-vision.com
About PRIMA US Feasibility Study
CLINICAL STUDY ADVANCED DRY AMD
The PRIMA feasibility study aims to evaluate the vision of patients with advanced dry AMD who are treated with a PRIMA Implant System.
This technology utilizes a retina implant inserted into the eye. Combined with a pair of special glasses.
To take part in this clinical study, you must:
- Be suffering from advanced dry AMD;
- Be 60 years or older and;
- Have a visual acuity of 20/400 or worse in your worst seeing eye.
If you cannot read the title of this website with your worst eye, you may qualify.
Other inclusion and exclusion criteria need to be confirmed by an ophthalmologist participating in the clinical study.
For additional criteria please consult this study doctor.
The PRIMA System
The PRIMA system consists of three main elements:
· The tiny wireless retinal implant
· A pair of glasses with an integrated camera and a projection module
· A pocket computer connected to the glasses
The mini camera integrated in the glasses captures images of the environment. These images are processed by the pocket computer to extract useful information from the visual scene.
The processed images are sent back to the glasses and are projected onto the PRIMA implant at the back of the eye.
The photovoltaic cells of the implant convert the optical information from the projection module into electrical stimulation which excite the nerve cells of the retina to induce visual perception.
Clinical Study
PRIMA has been tested in the laboratory and it is currently tested in a clinical feasibility study.
The aim of this clinical study is to evaluate the safety and the performance of the device.
Participants will undergo the following principal procedures:
- Explanation of all details of the study and signing the written informed consent form
- Ophthalmological assessment and vision testing
- Implantation of PRIMA
- Follow up examinations and intensive outpatient rehabilitation
The study period is 36 months. Most of the rehabilitation sessions will be done in the first 12 months after implantation.
The study doctor will provide additional details about the study procedures and risks. They are further explained in the informed consent form.
Please contact the study team if you are interested in participating in this study.