NCT03333954

Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Science Corporation · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

In this study, the principle functionality of the device will be tested in humans for the first time. The study will evaluate the extent to which patients with atrophic dry age related macular degeneration (AMD) have evoked light perception using the implant.

Detailed description

In this study subjects are provided with a PRIMA sub-retinal implant in one eye. A camera integrated in the external components of the implant captures visual information of the environment, this information is processed by a pocket processor and then transmitted via projected IR light onto the implant. The implant received the projected IR light and stimulates the nerve cells of the retina. Interim analysis will be performed at 6 months after implantation.

Conditions

• Dry Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	PRIMA Bionic Vision System	The PRIMA Bionic Vision System is a device for treatment of patients who have lost their sight through outer retinal degenerative conditions of the eye such as atrophic dry age related macular degeneration. The PRIMA System is designed to provide partial restoration of the patient's visual function through electrical stimulation of the retinal neurons by a sub-retinally implanted stimulator that replace part of the degenerate photoreceptors

Timeline

• Start date: 2017-11-06
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2017-11-07
• Last updated: 2026-04-02

Locations

1 site across 1 country: France