Pilot study EST I
The pilot study conducted at the University Eye Clinic Tübingen has shown that the TES therapy with the OkuStim System is safe and can have positive effects on the course of the disease in RP patients.(3)
ClinicalTrials.gov Identifier: NCT00804102
Publication: (3) Schatz et al., 2011
Long term study EST II
The second long-term study conducted at the University Eye Clinic Tübingen confirmed the safety of the weekly application of TES therapy over a twelve months horizon and showed a significant improvement in cellular activity in the retina, pointing towards a deceleration of disease progression.(4)
ClinicalTrials.gov Identifier: NCT01837901
Publication: (4) Schatz et al., 2017
Post Market Clinical Follow-Up
In the course of the „TESOLA“ post market follow-up study, which ran over 24 weeks in eleven European clinical centres from Oslo to Florence with 105 RP-patients, the safety of the TES therapy with the OkuStim System was again confirmed.(5,6)
Results of Clinical Investigations in Context
Clinical studies show that TES triggers physiological processes in the retina of RP patients. The application immediately causes a significant increase in blood flow to the central retina  and increased oxygen consumption of retinal cells . Randomized, controlled studies with weekly application also showed a significant improvement in visual acuity , visual field [3, 5], and improved b-wave amplitudes in the dark-adapted  and light-adapted ERG . The effect of TES appears to be transient, suggesting long-term application .
The safety of the application of the OkuStim system has been clearly proven in all clinical investigations, including a multi-centre post market observational study in 11 European clinics (TESOLA) [8, 9].
All clinical studies conducted with the OkuStim System to date have consistently demonstrated the safety of using TES therapy in outpatient and home settings. More than 300 patients have participated in the studies and have used the therapy for 130 years, including mre than 60 years in home use. In a total of more than 3,600 hours of stimulation, no serious adverse event related to the device or therapy occurred. Although the clinical data from the various studies do not yet provide a consistent picture of clinically relevant long-term effects, they do indicate significant effects of TES on photoreceptor function and a positive effect on the visual field and visual acuity. In recognition of this, the German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed that TES therapy with the OkuStim System has the potential for patient-relevant benefits .
Patient care and support
On the basis of the data obtained so far, the TES therapy is classified as safe by the Arbeitskreis Klinische Fragen (AKF) of PRO RETINA e.V., so that it can also be used outside the context of studies in RP patients. Furthermore, there are no objections to the use of the treatment in other generalised hereditary retinal dystrophies (cone and rod dystrophies, choroideremia, Usher syndrome, etc.) .
The OkuStim system is only available on prescription.
A constantly growing network of eye clinics is available as Competence Centres for patients. The OkuStim system is available at selected Low-Vision-Opticians and through international distributors. Detailed informationen on the international availabiliy of the therapy you can find here.