Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study)

  1. Jolly, Jasleen K.
  2. Wagner, Siegfried K.
  3. Martus, Peter
  4. MacLaren, Robert E.
  5. Wilhelm, Barbara
  6. Webster, Andrew R.
  7. Downes, Susan M.
  8. Charbel Issa, Peter
  9. Kellner, Ulrich
  10. Jägle, Herbert
  11. Rüther, Klaus
  12. Bertelsen, Mette
  13. Bragadóttir , Ragnheiður
  14. Prener Holtan, Josephine
  15. van den Born, L. Ingeborgh
  16. Sodi, Andrea
  17. Virgili, Gianni
  18. Gosheva, Mariya
  19. Pach, Johanna
  20. Zündorf, Ida
  21. Zrenner, Eberhart
  22. Gekeler, Florian

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1000 Titel
  • Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study)
1000 Autor/in
  1. Jolly, Jasleen K. |
  2. Wagner, Siegfried K. |
  3. Martus, Peter |
  4. MacLaren, Robert E. |
  5. Wilhelm, Barbara |
  6. Webster, Andrew R. |
  7. Downes, Susan M. |
  8. Charbel Issa, Peter |
  9. Kellner, Ulrich |
  10. Jägle, Herbert |
  11. Rüther, Klaus |
  12. Bertelsen, Mette |
  13. Bragadóttir , Ragnheiður |
  14. Prener Holtan, Josephine |
  15. van den Born, L. Ingeborgh |
  16. Sodi, Andrea |
  17. Virgili, Gianni |
  18. Gosheva, Mariya |
  19. Pach, Johanna |
  20. Zündorf, Ida |
  21. Zrenner, Eberhart |
  22. Gekeler, Florian |
1000 Verlag
  • S. Karger AG
1000 Erscheinungsjahr 2019
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2019-11-26
1000 Erschienen in
1000 Quellenangabe
  • 63(3):234-243
1000 Copyrightjahr
  • 2019
1000 Embargo
  • 2020-05-30
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1159/000505001 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Transcorneal electrical stimulation (TES) has been suggested as a possible treatment for retinitis pigmentosa (RP). &lt;b&gt;&lt;i&gt;Objective:&lt;/i&gt;&lt;/b&gt; To expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; This single-arm open label interventional safety trial included a total of 105 RP patients from 11 European centers, who received weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure was safety, indicated by the frequency and severity of adverse events. Secondary measures included intraocular pressure and central retinal thickness. Visual field and visual acuity were examined using the methods available at each site. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Dry eye sensation was the most common adverse event recorded (37.5%). Serious adverse events secondary to TES were not observed. Most adverse events were mild and all resolved without sequelae. The secondary outcome measures revealed no significant or clinically relevant changes. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; The present results confirm the excellent safety profile of TES. Transient dry eye symptoms were the most common adverse event.</jats:p>
1000 Sacherschließung
lokal Electric Stimulation Therapy/instrumentation [MeSH]
lokal Adolescent [MeSH]
lokal Female [MeSH]
lokal Transcorneal electrical stimulation
lokal Follow-Up Studies [MeSH]
lokal Retinal dystrophy
lokal Aged, 80 and over [MeSH]
lokal Aged [MeSH]
lokal Adult [MeSH]
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Treatment Outcome [MeSH]
lokal Retinitis Pigmentosa/diagnosis [MeSH]
lokal Middle Aged [MeSH]
lokal Intraocular Pressure/physiology [MeSH]
lokal Retinitis pigmentosa
lokal Visual Acuity [MeSH]
lokal Male [MeSH]
lokal Young Adult [MeSH]
lokal Electroretinography [MeSH]
lokal Retinitis Pigmentosa/therapy [MeSH]
lokal Equipment Design [MeSH]
lokal Research Article
1000 Liste der Beteiligten
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