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

Jasleen K Jolly, Siegfried K Wagner, Peter Martus, Robert E MacLaren, Barbara Wilhelm, Andrew R Webster, Susan M Downes, Peter Charbel Issa, Ulrich Kellner, Herbert Jägle, Klaus Rüther, Mette Bertelsen, Ragnheiður Bragadóttir, Josephine Prener Holtan, L Ingeborgh van den Born, Andrea Sodi, Gianni Virgili, Mariya Gosheva, Johanna Pach, Ida ZündorfEberhart Zrenner, Florian Gekeler

Research output: Contribution to journalArticleResearchpeer-review

Abstract

BACKGROUND: Transcorneal electrical stimulation (TES) has been suggested as a possible treatment for retinitis pigmentosa (RP).

OBJECTIVE: To expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

METHODS: 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.

RESULTS: 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.

CONCLUSION: The present results confirm the excellent safety profile of TES. Transient dry eye symptoms were the most common adverse event.

Original languageEnglish
Pages (from-to)234-243
Number of pages10
JournalOphthalmic Research
Volume63
Issue number3
DOIs
Publication statusPublished - 2020

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