Studies with predecessor models
Pilot study with RETINA IMPLANT Alpha IMS (1st generation)
The first generation of the sub-retinal implant did not yet have an induction coil for energy transmission and therefore only stayed in the patient’s body for a few weeks. Between 2005 and 2009, eleven patients received the wired RETINA IMPLANT Alpha IMS. This study provided proof of principle, i.e. it was possible to achieve useful visual impressions with the aid of sub-retinal stimulation, up to being able to read large print.
Wilke et al., Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003.
Kusnyerik et al., Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55.
Stingl et al., Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19; 54(12):7658-65.
Positive visual results were shown in all studies. It was shown that the subretinal implant could restore partial functional vision in adult patients who had lost sight due to degeneration of the retina. This was then able to restore a certain amount of independence in day-to-day life for those patients. The side effects were mainly mild and resolved within a short period of time or could be treated surgically without any subsequent problems.
Reimbursement of costs
The first NUB application (for new examination and treatment methods) for the subretinal implant was submitted in 2005 to the Institut für Entgeltsystem im Krankenhaus (Institute for Payment Systems in Hospitals, InEK).
The NUB process promotes the introduction of innovation in the German healthcare system because the methods falling under the NUB process cannot be invoiced via the flat-rate payment system. NUB applications have to be submitted by clinics to the InEK every year by 31 October.
Since its initial application in 2005, the subretinal implant has always received status level 1. This status enables the clinic to negotiate rates with the regional cost centres. While any clinic can submit an NUB application for the RETINA IMPLANT Alpha AMS in theory, as a result of the complexity of the implantation of a subretinal implant and in order to minimise all medical risks, Retina Implant cooperates with a select group of RI Implantation Centres and their specially trained retinal surgeons. These RI Implantation Centres are university clinics and leading teaching hospitals.
Since 2014, our RI Implantation Centres have successfully negotiated with the health insurers on charges. This means that the subretinal RETINA IMPLANT Alpha AMS is available to patients with congenital retinitis pigmentosa, among other conditions (link to “Use”). Depending on the agreement, however, an individual insurance reimbursement request may have to be submitted to the patient’s health insurer prior to the implantation.
Several clinics and surgeons are currently undergoing our validation process in other European countries, too, including the UK and the Netherlands, or have already successfully completed it. In close collaboration with our local clinical partners, we are working towards securing reimbursement so that people outside of Germany who are affected by RP can also benefit from the innovative RETINA IMPLANT Alpha AMS. Please click here for the current status of our clinical partners.
Medical postoperative care and training
Both the medical postoperative care and training take place in an outpatient setting. The medical postoperative care is carried out by doctors who have experience with the RETINA IMPLANT Alpha AMS. The medical care of the implant user is the responsibility of the centre carrying out the surgery and comprises recording the tolerability and safety of the implant by direct observation of the RETINA IMPLANT Alpha AMS in the eye, as well as standard imaging procedures. The medical postoperative care is carried out by an experienced team of doctors, orthoptists (experienced in the care of people with severely restricted vision and blindness) and nursing staff.
Functional postoperative care
The functional postoperative care in terms of instruction and vision training is carried out by qualified RI Patient Care Managers and/or mobility trainer, who are experienced in dealing with RETINA IMPLANT patients and in performance tests and mobility training. The training primarily takes place in the first few months after the implantation because previous experience has shown us that this is when the biggest learning processes take place. The training is generally carried out in the home environment of the implant user. In this way, the user is able to learn how to use the implant in everyday situations around the home, at the table and to find their way around buildings. The user also practises their orientation outdoors, both near to home and further away. The aim is to help patients familiarise themselves with their new ability to see within their environment and to return to them a degree of independence.
The functional postoperative care in terms of technical support is also carried out by qualified Patient Care Managers. Working together with the patient, they establish individual stimulation parameters and check the technical functioning of the implant if required.