Electrical Stimulation for the Eyes

Electrical Stimulation for the Eyes

Transcorneal electrical stimulation with the OkuStim® System:
an externally applied treatment for retinal dystrophies.

A Treatment Perspective

Electrical stimulation therapy with the OkuStim® System can help to slow down the narrowing of the visual field in retinitis pigmentosa, a degenerative retinal disease, and thus retain usable vision for longer.

Preclinical studies have shown electrical stimulation with weak currents to activate signaling pathways the in affected retina that have a protective effect on retinal cells. This neuroprotective effect can delay retinal degeneration and preserve the function of the remaining cells (1,2). This effect can be measured or examined by molecular tests and by electrophysiological measurements, such as an electroretinogram (ERG) which shows the electrical activity of the photoreceptors in response to light stimulation.

Okuvision has developed the transcorneal electrical stimulation (TES) therapy with the OkuStim® System to deliver weak electric currents to the eye and elicit the neuroprotective effects in the retina.

After an induction by a health-professional the therapy can be used independently at home. The safety of the OkuStim® application has been demonstrated in three different clinical studies (3-6) and confirmed by an expert panel of the patient organization PRO RETINA as safe for use in generalised retinal dystrophies.


[Translate to Englisch:] Abbildung der drei Elemente der OkuStim®-Therapie

The OkuStim® System

The OkuStim® System consists of three components: the OkuStim® device, the OkuSpex® frame and the OkuEl® elektrodes. The OkuStim® device applies a weak stimulating electric current to the eyes via the OkuEl® elektrodes.

 

[Translate to Englisch:] Abbildung der RI OkuSpex®-Brille

The OkuSpex® Frame

The OkuSpex® frame keeps the electrodes in the right position on the eyes. It can be easily adjusted to suit the individual shape of the face.

 

[Translate to Englisch:] Abbildung der RI OkuEl®-Elektroden

The OkuEl® Electrodes

OkuEl® electrodes are very delicate, 100 μm thin electrode threads which are placed on the surface of the eye just above the lower eyelid.
They are designed to be single-use. During stimulation they can hardly be felt by patients. With a bit of practice users can easily insert them into the OkuSpex® frame without any help.

 

[Translate to Englisch:] Abbildung des RI OkuStim®-Geräts

The OkuStim® Device

The memory card of the OkuStim® device contains the patient-individual treatment parameters, set by the doctor. The OkuStim® comprises a display and audio feedback for all essential functions so it can be easily used even by patients with advanced stages of visual impairment.


[Translate to Englisch:] Abbildung des OkuStim®-Geräts

Beginning with the TES Therapy

Operating the OkuStim® System for transcorneal electrical stimulation is easy, so that the therapy, at the doctor's discretion, can be carried out without supervision in the patient's home.

After a thorough ophthalmological examination the individual treatment parameters are determined for the individual patient and saved on the memory card of the OkuStim® device. The patient can then commence stimulation.

Users are recommended to attend bi-annual follow-up visits at their eye clinic.

[Translate to Englisch:] Abbildung der RI OkuSpex®-Brille

The Application

On the basis of clinical investigations we currently recommended one 30-minutes stimulation session per week. 

During the applicaiotn of the therapy the patient is recommended to keept the eyes closed. The OkuStim® device continuously monitors the electrical resistance. The therapy can be paused at any time by pressing the pause-button

Clinically tested

In the context of clinical investigations to-date, the TES therapy with the OkuStim® has been used by approx. 170 patients, also over longer timeframes.

Pilot study EST I

The pilot study conducted at the University Eye Clinic Tübingen has shown that the TES therapy with the OkuStim® System is safe and can have positive effects on the course of the disease in RP patients.(3)

 

ClinicalTrials.gov Identifier: NCT00804102
Publication: (3) Schatz et al., 2011

 

Long term study EST II

The second long-term study conducted at the University Eye Clinic Tübingen confirmed the safety of the weekly application of TES therapy over a twelve months horizon and showed a significant improvement in cellular activity in the retina, pointing towards a deceleration of disease progression.(4)

ClinicalTrials.gov Identifier: NCT01837901
Publication: (4) Schatz et al., 2017

Post Market Clinical Follow-Up

In the course of the „TESOLA“ post market follow-up study, which ran over 24 weeks in eleven European clinical centres from Oslo to Florence with 105 RP-patients, the safety of the TES therapy with the OkuStim® System was again confirmed.(5,6)


ClinicalTrials.gov Identifier: NCT01835002 (TESOLA), NCT01847365 (TESOLA UK)
Publikationen: (5) Wagner et al., 2017;
(6) Jolly et al., 2019

 

Download: Fact Sheet Clnical Investigations German / Englisch

 

My Therapy

We are happy to answer all your questions on the way to your TES therapy. You can find more information about the required steps here.

If the TES therapy with the OkuStim System is not yet available in your country or you have general questions, please do not hesitate to get in touch.

 


SOURCES

  1. Fu L, Lo AC, Lai JS, Shih KC. The role of electrical stimulation therapy in ophthalmic diseases. Graefes Arch Clin Exp Ophthalmol. 2015;253(2):171-6.
  2. Pardue MT, Allen RS. Neuroprotective strategies for retinal disease. Prog Retin Eye Res. 2018;65:50-76.
  3. Schatz A, Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, et al. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011;52(7):4485-96.
  4. Schatz A, Pach J, Gosheva M, Naycheva L, Willmann G, Wilhelm B, et al. Transcorneal Electrical Stimulation for Patients With Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Follow-up Study Over 1 Year. Invest Ophthalmol Vis Sci. 2017;58(1):257-69.
  5. Wagner SK, Jolly JK, Pefkianaki M, Gekeler F, Webster AR, Downes SM, et al. Transcorneal electrical stimulation for the treatment of retinitis pigmentosa: results from the TESOLAUK trial. BMJ Open Ophthalmol. 2017;2(1):e000096.
  6. 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., Zündorf, I., Zrenner, E. & Gekeler, F. 2019. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study). Ophthalmic Research.