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Electric Stimulation of the Eye to Improve Vision After Trauma

NCT02019927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-01-18

Study results available
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Summary

Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.

Conditions

  • Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
  • Trauma
  • Multiple Sclerosis (MS)

Interventions

DEVICE

Transcorneal Electrical Stimulation

The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.

DEVICE

Sham

Sham

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Wills Eye

    lead OTHER

Principal Investigators

  • Julia Haller, MD · Wills Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019927 on ClinicalTrials.gov