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 pres-sure 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.
Bibliographical noteFunding Information:
The clinical trial was cofunded by Okuvision GmbH. E.Z. was supported by a DFG grant to the DFG Center of Excellence (EXC 307)
© 2020 S. Karger AG, Basel.
Copyright 2020 Elsevier B.V., All rights reserved.
- Retinal dystrophy
- Retinitis pigmentosa
- Transcorneal electrical stimulation
ASJC Scopus subject areas
- Sensory Systems
- Cellular and Molecular Neuroscience