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Transkorneale Elektrostimulation bei primärem Offenwinkelglaukom

Transcorneal electrical stimulation in primary open angle glaucoma

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Zusammenfassung

Neuere Berichte über die Wirksamkeit transkornealer elektrischer Stimulation bei Patienten und Versuchstieren mit neurodegenerativen Augenerkrankungen veranlassten uns zur Durchführung einer wissenschaftlichen Untersuchung der Elektrostimulation bei primärem Offenwinkelglaukom (POWG). Die Zielparameter unserer Studie waren die Erfassung von möglichen unerwünschten Ereignissen sowie die Wirksamkeit der transkornealen Elektrostimulation (TES) durch Bestimmung subjektiver und objektiver Parameter der Sehfunktion. Es wurden 14 Patienten in 3 Gruppen randomisiert aufgeteilt und mit 0 % (Scheinstimulation, n = 5), 66 % (n = 5) oder 150 % (n = 4) ihrer individuellen Schwelle für elektrisch ausgelöste Phosphene über 6 Wochen 1‑mal wöchentlich für 30 min stimuliert. Es konnten keine schwerwiegenden unerwünschten Ereignisse festgestellt werden; die Verträglichkeit der TES mittels DTL-Elektroden war insgesamt gut. Die Entwicklung einer papillären Randblutung eines scheinstimulierten Auges wurde als einziges unerwünschtes Ereignis verzeichnet. Zusammenfassend konnte nur ein signifikanter Unterschied der intraindividuellen Veränderungen zur Basisuntersuchung zwischen den Gruppen erfasst werden. Der Augeninnendruck in der 66 % stimulierten Gruppe war signifikant höher als in der Scheinstimulationsgruppe (p = 0,04), jedoch fanden wir keine signifikanten Unterschiede zur 150 %-Gruppe (weder Scheinstimulation vs. 150 % noch 66 % vs. 150 %). Der Unterschied (mittlere Differenz zur Anfangsuntersuchung −2,33 mm Hg für die Scheinstimulationsgruppe und 0,97 mm Hg für die 66 %-Gruppe; REML) war klinisch nicht relevant. Alle anderen Untersuchungen, insbesondere das Gesichtsfeld, erbrachten keine signifikanten Unterschiede. Es konnte gezeigt werden, dass TES mittels DTL-Elektroden bei Patienten mit POWG zu keinen unerwünschten oder schwerwiegenden unerwünschten Ereignissen in den stimulierten Gruppen führte. Die Anwendung der TES für Patienten mit POWG ist momentan jedoch nur unter Studienbedingungen zu empfehlen.

Abstract

Recently, reports have been published on the effectiveness of electrical stimulation in patients and experimental animal models with neurodegenerative ocular diseases. Our study included 14 patients with primary open angle glaucoma (POAG), who were randomized into one of three groups with 0% (sham, n = 5), 66% (n = 5) or 150% (n = 4) of their individual electrical phosphene thresholds. Patients were treated with transcorneal electrical stimulation (TES) for 30 min once a week for 6 consecutive weeks. Outcome measures of our study were the detection of possible adverse events and efficacy of TES using DTL electrodes in subjective and objective parameters of visual function under treatment. TES was tolerated well and no serious adverse events were registered relating to the treatment. One single adverse event was registered as appearance of an optic disc hemorrhage of a sham-stimulated eye. In summary, one significant increase of intra-ocular pressure in the 66% group was observed in comparison to the sham group (p = 0.04), without significant differences compared to the 150% group (both sham vs. 150% group and 66% vs. 150% group). This difference (mean difference compared to baseline of −2.33 mm Hg for the sham group and +0.97 mm Hg for the 66% group; REML) was not clinical meaningful. All other findings, including results of the visual field, were not statistically significant different between groups. It was shown that TES using DTL electrodes did not trigger adverse or serious adverse events in the stimulated groups in patients with POAG. Patients with POAG should currently receive TES only under study conditions.

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Förderung

Finanzielle Unterstützung zur Durchführung der Studie: Okuvision GmbH, Reutlingen, Deutschland

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Authors and Affiliations

  1. Department für Augenheilkunde, Eberhard Karls Universität Tübingen, Tübingen, Deutschland

    T. Röck, G. Willmann, E. Zrenner, K. U. Bartz-Schmidt, F. Gekeler &  A. Schatz

  2. Klinik für Augenheilkunde, Universitätsklinikum Frankfurt, Frankfurt am Main, Deutschland

    L. Naycheva

  3. STZ eyetrial am Department für Augenheilkunde, Eberhard Karls Universität Tübingen, Tübingen, Deutschland

    B. Wilhelm & T. Peters

  4. Augenklinik am Katharinenhospital, Klinikum Stuttgart, Kriegsbergstr. 60, 70329, Stuttgart, Deutschland

    G. Willmann, F. Gekeler &  A. Schatz

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  1. T. Röck
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  2. L. Naycheva
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  3. G. Willmann
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  4. B. Wilhelm
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  7. K. U. Bartz-Schmidt
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  8. F. Gekeler
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  9. A. Schatz
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Correspondence to A. Schatz.

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Interessenkonflikt

T. Röck, L. Naycheva, G. Willmann, B. Wilhelm, T. Peters, E. Zrenner, K.U. Bartz-Schmidt, F. Gekeler und A. Schatz geben an, dass kein Interessenkonflikt besteht.

Alle im vorliegenden Manuskript beschriebenen Untersuchungen am Menschen wurden mit Zustimmung der zuständigen Ethik-Kommission, im Einklang mit nationalem Recht sowie gemäß der Deklaration von Helsinki von 1975 (in der aktuellen, überarbeiteten Fassung) durchgeführt. Von allen beteiligten Patienten liegt eine Einverständniserklärung vor.

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Röck, T., Naycheva, L., Willmann, G. et al. Transkorneale Elektrostimulation bei primärem Offenwinkelglaukom. Ophthalmologe 114, 922–929 (2017). https://doi.org/10.1007/s00347-016-0415-5

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