September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Transcorneal electrical stimulation for patients with retinitis pigmentosa – Safety and efficacy evidence from a multicentric observation study – TESOLA
Author Affiliations & Notes
  • Andreas Schatz
    Department of Ophthalmology, Stuttgart, Germany
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Johanna Pach
    Department of Ophthalmology, Stuttgart, Germany
  • Mariya Gosheva
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Barbara Wilhelm
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Tobias Peters
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Peter Martus
    Department of Epidemiology and Biostatistics, Tuebingen, Germany
  • Ida Zündorf
    Okuvision GmbH, Reutlingen, Germany
  • Karl-Ulrich Bartz-Schmidt
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Eberhart Zrenner
    Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Florian Gekeler
    Department of Ophthalmology, Stuttgart, Germany
  • Footnotes
    Commercial Relationships   Andreas Schatz, Okuvision GmbH (F); Johanna Pach, Okuvision GmbH (F); Mariya Gosheva, Okuvision GmbH (F); Barbara Wilhelm, Okuvision GmbH (F); Tobias Peters, Okuvision GmbH (F); Peter Martus, Okuvision GmbH (F); Ida Zündorf, Okuvision GmbH (E); Karl-Ulrich Bartz-Schmidt, None; Eberhart Zrenner, Okuvision GmbH (F); Florian Gekeler, Okuvision GmbH (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 138. doi:
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      Andreas Schatz, Johanna Pach, Mariya Gosheva, Barbara Wilhelm, Tobias Peters, Peter Martus, Ida Zündorf, Karl-Ulrich Bartz-Schmidt, Eberhart Zrenner, Florian Gekeler; Transcorneal electrical stimulation for patients with retinitis pigmentosa – Safety and efficacy evidence from a multicentric observation study – TESOLA. Invest. Ophthalmol. Vis. Sci. 2016;57(12):138.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The multicentric observational study was performed to verify the safety and efficacy of transcorneal electrical stimulation (TES) in a large number of patients with retinitis pigmentosa (RP).

Methods : 105 patients (mean age 46 ± 15.9; 58 males) underwent TES (5-ms biphasic pulses@20 Hz, 30 minutes/week for 6 months) using the OkuStim®-system (Okuvision GmbH, Germany) and finished the study per protocol. All patients were stimulated in one eye with 150% stimulation current of their individual electrical phosphene threshold. Patients were stimulated at home after a 4-week training in the clinic (n=32) or in the clinic (n=73). Primary outcome was safety; secondary endpoints were efficacy measurements via visual field and visual acuity; additional intraocular pressure (IOP) and optical coherence tomography (OCT) were performed. Patients were examined at baseline (week 1), during weeks 12, and 24 (stimulation) as well as weeks 36 and 48 (follow up examinations during stimulation free period).

Results : 97 patients completed the study per protocol. Most adverse events (AE) were dry eye symptoms reported by patients (37.5% of all AE). No serious AEs related to the treatment were observed; no serious AEs related to the treatment were reported during the follow up examinations. The efficacy analyses revealed significant improvement in the BCVA in the stimulated eye (MANOVA; p < 0.05), while no changes were observed in the fellow eye (MANOVA; p > 0.05). Moreover positive trend showing improvements in the visual fields of the stimulated eye as compared to the fellow eye was observed (Ranks test; p = 0.084). No significant effect on IOP or OCT were observed during stimulation.

Conclusions : TES was found to be safe; AEs were mainly dry eye symptoms treatable by artificial tears. Significant improvements in visual acuity and the positive tendency in visual fields observed in the stimulated eyes demonstrate the efficacy of TES in RP patients. The majority of patients reported to be satisfied with the therapy.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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