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The eye and retinal degeneration

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.

The retinal implant solution

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.

The clinical trial

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.

1

Following eligibility tests including ophthalmological and psychological exams, the implant is implanted in one of the eyes under general anesthesia by a senior retinal surgeon.

2

Patients 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.

3

After 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.

4

During 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.

5

The 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.

6

Candidates for participation in the study

Retinitis Pigmentosa patients who

meet the following criteria:

  • Adults 18 years and older
  • People suffering from blindness at the level of light perception up to no light perception in both eyes.

*For clinical trial use only. The system has not yet been approved for commercial use.

For more details:

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 | +972-3-6973629

Rabin Medical Center (Belinson)

Vivi Daganeyeclinic@clalit.org.il

+972-3-9377199

Belgium: Leuven University Hospital

Ingeborg Vriensingeborg.vriens@uzleuven.be

+32 16 34 22 29

Gent University Hospital

Caroline Van CauwenberghCaroline.vancauwenbergh@ugent.be

+32 93 32 53 52

Italy: Agostino Gemelli University Policlinico, Rome

Marco Sulfarom.sulfaro@iapb.it


San Raffaele University Hospital, Milan

Lorenzo IulianoIuliano. lorenzo@hsr.it

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