NCT01835002

Transcorneal Electrical Stimulation - Multicenter Safety Study

Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Okuvision GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

Detailed description

This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DEVICE	Transcorneal electrostimulation	Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2015-08-01
• First posted: 2013-04-18
• Last updated: 2021-03-04

Locations

7 sites across 3 countries: Denmark, Germany, Norway