Andreas Schatz1, Johanna Pach2, Mariya Gosheva3, Lubka Naycheva4, Gabriel Willmann1, Barbara Wilhelm5, Tobias Peters5, Karl Ulrich Bartz-Schmidt3, Eberhart Zrenner3, André Messias6, Florian Gekeler1. 1. Centre for Ophthalmology, University of Tübingen, Tübingen, Germany 2Department of Ophthalmology, Klinikum Stuttgart, Stuttgart, Germany. 2. Department of Ophthalmology, Klinikum Stuttgart, Stuttgart, Germany. 3. Centre for Ophthalmology, University of Tübingen, Tübingen, Germany. 4. Department of Ophthalmology, Goethe University Frankfurt am Main, Frankfurt am Main, Germany. 5. STZ eyetrial at the Centre for Ophthalmology, University of Tübingen, Tübingen, Germany. 6. Department of Ophthalmology, Otorhinolaryngology and Head & Neck Surgery, University of São Paulo, Ribeirão Preto, Brazil.
Abstract
Purpose: After promising results of an exploratory study, this study was designed to assess the safety and efficacy of transcorneal electrical stimulation (TES) over 1 year in patients with retinitis pigmentosa (RP). Methods: We included 52 RP patients in this prospective, randomized, partially-masked study which was done in accordance with rules of good clinical practice. Transcorneal electrical stimulation by Okustim was applied monocularly for 30 minutes per week for 52 consecutive weeks. Patients were assigned randomly to the groups: sham, 150%, or 200% of individual electrical phosphene threshold (EPT). Visual acuity (retroilluminated Snellen charts), visual field (VF; Octopus 900), electroretinography (ERG), rod and cone full-field stimulus threshold, EPTs and IOP were assessed. Primary outcome measures were VF area; secondary outcome measures were development of ERG parameters. Results: The application of TES was tolerated well. Dry eye symptoms (31 of 52 patients) were registered as the main adverse event. Throughout the study period, the VF area showed only a trend for prevention of VF loss in the 200% group (P = 0.24). A significant improvement of light-adapted single flash b-wave was noted for the 200% (P < 0.0001) and 150% (P = 0.006) groups compared to the sham group. Tendencies of improved function were observed for scotopic b-wave amplitude for the 200% group (P = 0.097). Other examination methods did not reach statistical significance. Conclusions: The safety and acceptable tolerability of weekly TES self-administered by patients at home was confirmed over the course of 1 year. Objectively measured improvements in retinal function with ERG provide support for the potential benefits of TES for RP patients.
RCT Entities:
Purpose: After promising results of an exploratory study, this study was designed to assess the safety and efficacy of transcorneal electrical stimulation (TES) over 1 year in patients with retinitis pigmentosa (RP). Methods: We included 52 RP patients in this prospective, randomized, partially-masked study which was done in accordance with rules of good clinical practice. Transcorneal electrical stimulation by Okustim was applied monocularly for 30 minutes per week for 52 consecutive weeks. Patients were assigned randomly to the groups: sham, 150%, or 200% of individual electrical phosphene threshold (EPT). Visual acuity (retroilluminated Snellen charts), visual field (VF; Octopus 900), electroretinography (ERG), rod and cone full-field stimulus threshold, EPTs and IOP were assessed. Primary outcome measures were VF area; secondary outcome measures were development of ERG parameters. Results: The application of TES was tolerated well. Dry eye symptoms (31 of 52 patients) were registered as the main adverse event. Throughout the study period, the VF area showed only a trend for prevention of VF loss in the 200% group (P = 0.24). A significant improvement of light-adapted single flash b-wave was noted for the 200% (P < 0.0001) and 150% (P = 0.006) groups compared to the sham group. Tendencies of improved function were observed for scotopic b-wave amplitude for the 200% group (P = 0.097). Other examination methods did not reach statistical significance. Conclusions: The safety and acceptable tolerability of weekly TES self-administered by patients at home was confirmed over the course of 1 year. Objectively measured improvements in retinal function with ERG provide support for the potential benefits of TES for RP patients.
Authors: Marom Bikson; Zeinab Esmaeilpour; Devin Adair; Greg Kronberg; William J Tyler; Andrea Antal; Abhishek Datta; Bernhard A Sabel; Michael A Nitsche; Colleen Loo; Dylan Edwards; Hamed Ekhtiari; Helena Knotkova; Adam J Woods; Benjamin M Hampstead; Bashar W Badran; Angel V Peterchev Journal: Brain Stimul Date: 2019-07-17 Impact factor: 8.955
Authors: Maria Della Volpe-Waizel; Hanna Camenzind Zuche; Ursula Müller; Annekatrin Rickmann; Hendrik P N Scholl; Margarita G Todorova Journal: Graefes Arch Clin Exp Ophthalmol Date: 2019-11-12 Impact factor: 3.117
Authors: Annekatrin Rickmann; Maria Della Volpe Waizel; Olga Zabek; Hanna Camenzind Zuche; Ursula Müller; Hendrik P N Scholl Journal: Graefes Arch Clin Exp Ophthalmol Date: 2020-10-10 Impact factor: 3.117