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 Zündorf; Eberhart Zrenner; Florian Gekeler

doi:10.1159/000505001

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

Medical retina and Uveitis

Research output: Contribution to journal › Article › Research › peer-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 language	English
Pages (from-to)	234-243
Number of pages	10
Journal	Ophthalmic Research
Volume	63
Issue number	3
DOIs	https://doi.org/10.1159/000505001
Publication status	Published - 2020

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10.1159/000505001

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Jolly, J. K., Wagner, S. K., Martus, P., MacLaren, R. E., Wilhelm, B., Webster, A. R., Downes, S. M., Charbel Issa, P., Kellner, U., Jägle, H., Rüther, K., Bertelsen, M., Bragadóttir, R., Prener Holtan, J., van den Born, L. I., Sodi, A., Virgili, G., Gosheva, M., Pach, J., ... Gekeler, F. (2020). Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study). Ophthalmic Research, 63(3), 234-243. https://doi.org/10.1159/000505001

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title = "Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim{\textregistered} System (TESOLA-Study)",

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.",

author = "Jolly, {Jasleen K} and Wagner, {Siegfried K} and Peter Martus and MacLaren, {Robert E} and Barbara Wilhelm and Webster, {Andrew R} and Downes, {Susan M} and {Charbel Issa}, Peter and Ulrich Kellner and Herbert J{\"a}gle and Klaus R{\"u}ther and Mette Bertelsen and Ragnhei{\dh}ur Bragad{\'o}ttir and {Prener Holtan}, Josephine and {van den Born}, {L Ingeborgh} and Andrea Sodi and Gianni Virgili and Mariya Gosheva and Johanna Pach and Ida Z{\"u}ndorf and Eberhart Zrenner and Florian Gekeler",

note = "{\textcopyright} 2020 S. Karger AG, Basel.",

year = "2020",

doi = "10.1159/000505001",

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Jolly, JK, Wagner, SK, Martus, P, MacLaren, RE, Wilhelm, B, Webster, AR, Downes, SM, Charbel Issa, P, Kellner, U, Jägle, H, Rüther, K, Bertelsen, M, Bragadóttir, R, Prener Holtan, J, van den Born, LI, Sodi, A, Virgili, G, Gosheva, M, Pach, J, Zündorf, I, Zrenner, E & Gekeler, F 2020, 'Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study)', Ophthalmic Research, vol. 63, no. 3, pp. 234-243. https://doi.org/10.1159/000505001

TY - JOUR

T1 - Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa

T2 - A Multicenter Safety Study of the OkuStim® System (TESOLA-Study)

AU - Jolly, Jasleen K

AU - Wagner, Siegfried K

AU - Martus, Peter

AU - MacLaren, Robert E

AU - Wilhelm, Barbara

AU - Webster, Andrew R

AU - Downes, Susan M

AU - Charbel Issa, Peter

AU - Kellner, Ulrich

AU - Jägle, Herbert

AU - Rüther, Klaus

AU - Bertelsen, Mette

AU - Bragadóttir, Ragnheiður

AU - Prener Holtan, Josephine

AU - van den Born, L Ingeborgh

AU - Sodi, Andrea

AU - Virgili, Gianni

AU - Gosheva, Mariya

AU - Pach, Johanna

AU - Zündorf, Ida

AU - Zrenner, Eberhart

AU - Gekeler, Florian

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

UR - https://www.mendeley.com/catalogue/42de1b0c-d5cf-3ad9-9cc3-2cb36bb00b2e/

U2 - 10.1159/000505001

DO - 10.1159/000505001

M3 - Article

C2 - 31775146

SN - 0030-3747

VL - 63

SP - 234

EP - 243

JO - Ophthalmic Research

JF - Ophthalmic Research

IS - 3

ER -

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

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