Jasleen K Jolly1,2,3, Siegfried K Wagner1,2,3, Peter Martus4, Robert E MacLaren1,2,3, Barbara Wilhelm5, Andrew R Webster3,4, Susan M Downes1,2, Peter Charbel Issa1,2,6, Ulrich Kellner7, Herbert Jägle8, Klaus Rüther9, Mette Bertelsen10, Ragnheiður Bragadóttir11,12, Josephine Prener Holtan11,12, L Ingeborgh van den Born13, Andrea Sodi14, Gianni Virgili14, Mariya Gosheva15, Johanna Pach15,16,17, Ida Zündorf18, Eberhart Zrenner15,16, Florian Gekeler19,20,21. 1. Nuffield Laboratory of Ophthalmology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom. 2. Oxford Eye Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom. 3. Moorfields Eye Hospital, London, United Kingdom. 4. UCL Institute of Ophthalmology, London, United Kingdom. 5. STZ eyetrial at the Center for Ophthalmology, University of Tübingen, Tübingen, Germany. 6. Department of Ophthalmology, University of Bonn, Bonn, Germany. 7. Rare Retinal Disease Center, AugenZentrum Siegburg, Siegburg, Germany. 8. Department of Ophthalmology, University Hospital Regensburg, Regensburg, Germany. 9. Augenarztpraxis, Berlin, Germany. 10. Department of Clinical Genetics, Rigshospitalet, Copenhagen, Denmark. 11. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. 12. Oslo University, Oslo, Norway. 13. Rotterdam Eye Hospital, and Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands. 14. Eye Clinic, Careggi Teaching Hospital, Florence, Italy. 15. Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, Germany. 16. Center for Integrative Neuroscience, University of Tuebingen, Tuebingen, Germany. 17. Department of Ophthalmology, Klinikum Stuttgart, Stuttgart, Germany. 18. Okuvision GmbH, Reutlingen, Germany. 19. Centre for Ophthalmology, University Hospital Tuebingen, Tuebingen, Germany, fgekeler@googlemail.com. 20. Center for Integrative Neuroscience, University of Tuebingen, Tuebingen, Germany, fgekeler@googlemail.com. 21. Department of Ophthalmology, Klinikum Stuttgart, Stuttgart, Germany, fgekeler@googlemail.com.
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.
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.