The retina is the light-sensitive layer in the eye, comparable to a film in an analog camera. The retina is a thin nerve tissue that lines the inside of the eye and consists of several layers, with photoreceptors as the outermost layer. The photoreceptors convert the light that penetrates the eye into electrical signals and transmit them to cells in the inner layers of the retina, which process the information and pass it through the optic nerve to the visual centers in the brain, which complete vision processing into images. In hereditary retinal degenerations, the photoreceptors are injured and die. As a result, the light passing through the eye is not translated into vision. The disease leads to a continuous deterioration in vision up to complete vision loss. The inner layers of the retina however, remain functional.
It is now known that the function of the damaged photoreceptors can be mimicked by translating the image into electrical signals and transmitting a very low electrical current to the retinal cells in the layers that continue to function. In this way, the process of vision can be stimulated and the sense of sight can be restored to a certain extent.
An international trial investigating a retinal prosthetic implant is currently underway, designed to restore the sense of sight to people who have lost vision in both eyes due to the hereditary retinal degenerative disease Retinitis Pigmentosa.
1Following eligibility tests including ophthalmological and psychological exams, the implant is implanted in one of the eyes under general anesthesia by a senior retinal surgeon.
2Patients remain in the clinical center for recovery and follow-up for up to two days post-op, and after about two weeks the implant is activated using unique glasses provided to the patient, which transmit an invisible and harmless infrared beam into the eye.
3After non-invasive calibration of the implant by a qualified clinical technician, the medical research team will follow-up over six months to ensure eye health and to perform testing to assess the vision improvement that comes from using the implant.
4During the rehabilitation process the patients will receive guidance and training. Patients who consent will be granted an additional one-year follow-up by the medical center.
5The study is funded by the sponsor and does not involve financial expenses for the participants. The main purpose of the study is to demonstrate the safety of using the product and to evaluate how it functions in restoring vision capabilities to patients.
6meet the following criteria:
*For clinical trial use only. The system has not yet been approved for commercial use.
The Ophthalmological departments of the following clinical centers are currently actively recruiting patients for the study:
Israel: Sourasky Medical Center (Ichilov)
Sasha Amirov sashaa@tlvmc.gov.il
+972-3-6974165 | +972-3-6973629Belgium: Leuven University Hospital
Ingeborg Vriens ingeborg.vriens@uzleuven.be
+32 16 34 22 29Gent University Hospital
Caroline Van Cauwenbergh Caroline.vancauwenbergh@ugent.be
+32 93 32 53 52Italy: Agostino Gemelli University Policlinico, Rome
Marco Sulfaro m.sulfaro@iapb.it
San Raffaele University Hospital, Milan
Lorenzo Iuliano Iuliano. lorenzo@hsr.it