June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Transcorneal Electrical Stimulation (TES) results in a slowing of Visual Field (VF) progressive deterioration in Retinitis Pigmentosa (RP) patients
Author Affiliations & Notes
  • Carl Schubert
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Eberhart Zrenner
    Institute for Ophthalmic Research, University of Tübingen, Tübingen, Germany
  • Florian Gekeler
    Institute for Ophthalmic Research, University of Tübingen, Tübingen, Germany
  • Andreas Schatz
    Institute for Ophthalmic Research, University of Tübingen, Tübingen, Germany
  • Larry A Donoso
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Maria Pefkianaki
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Sarah Federman
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Krista Dedrick
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Jay L Federman, MD
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Darell Turner
    Research (PREF), Wills Eye Hospital, Philadelphia, PA
  • Footnotes
    Commercial Relationships Carl Schubert, None; Eberhart Zrenner, Okuvision GmbH (F); Florian Gekeler, Okuvision GmbH (F); Andreas Schatz, Okuvision GmbH (F); Larry Donoso, None; Maria Pefkianaki, None; Sarah Federman, None; Krista Dedrick, None; Jay L Federman, MD, Okuvision GmbH (C); Darell Turner, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3807. doi:
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      Carl Schubert, Eberhart Zrenner, Florian Gekeler, Andreas Schatz, Larry A Donoso, Maria Pefkianaki, Sarah Federman, Krista Dedrick, Jay L Federman, MD, Darell Turner; Transcorneal Electrical Stimulation (TES) results in a slowing of Visual Field (VF) progressive deterioration in Retinitis Pigmentosa (RP) patients. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3807.

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

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Abstract

Purpose: To perform an exploratory statistical analysis of the percentage of patients who show no change from baseline in the EST2 study (personal communication, Gekeler, et al, ARVO submission, 2015).<br />

Methods: A prospective randomized study was performed to confirm efficacy of TES in reducing the rate of VF loss in RP (EST2 study).<br /> Fifty two patients per protocol were treated with TES (using the OkuStim®, Okuvision GmbH, Germany) weekly for 30 minutes for 52 weeks, prospectively randomized into 3 groups (sham, 150%(TES150) & 200%(TES200) of current that elicited a phosphene threshold. Octopus VF area using III4e & V4e stimuli were measured for each patient. <br /> The difference between VF-III4e and VF-V4e isopter area was also analyzed to better represent the periphery. An exact binomial test was used to test if there were significant change from expected value in each of the groups at each visit. <br /> A Fisher’s exact test was used to compare the percentage of patients with no change in VF-III4e, VF-V4e and the difference between VF-III4e and VF-V4e at each visit relative to sham.<br />

Results: The expected value of the percentage of patients with no change from baseline for an effective treatment is .50. Statistical significance relative to the expected value indicates that the treatment was not completely effective. Both sham and TES150 groups showed significance (p<.05) at multiple visits. The TES200 group showed a significant difference at only 1 of 4 visits.<br /> A statistical trend (p<.10) was observed at Week 52 for percentage of patients with no change from baseline in VFV4e for TES200 relative to the sham group. A statistically significant difference (p<.05) was observed between TES200 and sham at week 78 in the difference between VF-III4e and VF-V4e. <br />

Conclusions: Results indicate that TES at the 200% treatment level of phosphene threshold may reduce the rate of progression of RP. The significant difference observed relative to sham may indicate that the effect is the result of the preclinically well established release of growth factors induced by electrostimulation suggesting a neurotrophic effect to the peripheral retina.<br /> <br />

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