PRIMA Bionic Vision System Clinical Feasibility Research Study

For patients with blindness due to atrophic dry age-related macular degeneration.

About the PRIMA Study

The PRIMA photovoltaic, subretinal Bionic Vision System, developed by Pixium Vision, is a wireless retinal implant currently being studied in patients who have lost their sight due to outer retinal degeneration, such as atrophic dry age-related macular degeneration (AMD). The objective of the clinical study is to evaluate the safety and performance of the PRIMA Bionic Vision System. PRIMA is an experimental system, and pre-clinical studies have demonstrated the initial safety of the device.

Criteria to participate in the study:

• Atrophic dry AMD
• 60 years or older
• Visual acuity of LogMAR 1.3 (20/400) or worse (beyond legal blindness)
• No foveal perception

For additional criteria, please consult ClinicalTrials.gov (NCT03392324). Other inclusion and exclusion criteria needs to be confirmed by ophthalmologist(s) participating in the clinical study.

What Results Are Expected from the Study?

Data and simulations available suggest that the wireless implant system will potentially allow participants to visualize and locate light sources, such as recognizing high-contrast objects and large-sized letters. This is the first study in humans. Currently, the benefit for the patient is not yet known.

The PRIMA Bionic Vision System

The PRIMA system aims to elicit functional artificial vision in the form of light visual perception and restoring vision loss. It consists of three main elements:

• Wireless subretinal photovoltaic implant
• Glasses with a camera
• Pocket computer

Wireless subretinal implant:
The implant, a small 2x2mm wide chip containing 378 photovoltaic cells, is implanted between the retinal cell layers.

Glasses with camera:
A mini camera mounted on the glasses captures images of the environment and transmits them to the pocket computer.

Pocket computer:
The computer interprets the information and transfers it back to the glasses, where a miniature projector sends it through the eye via infrared light to the implant. The chip, designed to recognize this infrared light, converts the information into a pattern of electrical impulses that are sent to the brain. The patient learns to interpret these impulses through training.

After implantation of the PRIMA chip, sessions for training and assessments of visual improvement are required. The study follow-up lasts up to 36 months.

These images are for illustrative purposes and not fully representative of the actual device used in the clinical study.

Read about the first results from the PRIMA trial in France.