Okuvision Schatz

Transkorneale Elektrostimulation von Patienten mit Retinitis pigmentosa

01/09/2015 to 31/08/2016

After promising results of the exploratory study in 24 patients over a course of 6 weeks (Schatz et al., IOVS 2011) this study was designed to assess the safety and efficacy of transcorneal electrical stimulation (TES) by subjective and objective parameters of visual function after one year of weekly stimulation in a larger cohort of patients with retinitis pigmentosa (RP).

Fifty-two patients in this prospective, randomized, partially-blinded, good-clinical-practice conform study received TES (5 ms biphasic pulses; 20 Hz; DTL electrodes) 30 minutes per week for 52 consecutive weeks. Patients were randomly assigned to one of three groups: sham, 150%, or 200% of individual electrical phosphene threshold (EPT). Visual acuity (VA), visual field (VF; kinetic, static), electroretinography (Ganzfeld, multifocal), dark-adaptation, EPTs and intra-ocular pressure (IOP) were assessed at all visits or 4 times according to the study plan. Primary outcome measures were development of visual field area (Goldmann III/4e), secondary outcome measures development of electroretinographic key parameters.

The results of the current study should be analyzed, summarized and reported in the current project.