Electric Stimulation of the Eye to Improve Vision After Trauma (TES)

January 6, 2020 updated by: Julia Haller, Wills Eye

Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma

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.

Study Overview

Detailed Description

The finely detailed, precise anatomy of the retina and optic nerve capture light impulses from the environment through a biochemical process and then transmit these images to the brain via electrical impulses conducted from the inner retina to the optic nerve and ultimately to the occipital cortex.

In the human eye, three types of specialized ganglion cells transmit electrical impulses to the brain. Among these three cell populations are rod and cone cells, which participate in the photo-transduction step of light perception, along with other light sensitive ganglion cells. It is a system whereby the photosensitive pigment rhodopsin (or one of its analogs) rearranges in response to light, and this change in chemical structure fires electrical impulses to the brain which in turn interprets the incoming impulses as a visual image.

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 VA and/or the visual field.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • You are 18 years or older.
  • You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study).
  • You are willing and able to give written informed consent.
  • You are able to commit to enrolling in the study during the full time period of up to 6 months.

Exclusion Criteria:

  • You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration).
  • You have amblyopia (lazy eye) in affected eye, previously diagnosed.
  • You are participating in any other interventional clinical trial.
  • If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening.
  • You are unable to give signed consent due to memory, medical, communication, language, or mental health problems.
  • You are less than 18 years old.
  • You are unable or unwilling to complete the evaluation or questionnaire.
  • Visual acuity better than 20/40
  • Inability to detect phosphenes during threshold detection
  • You are on seizure medications, or have a history of epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-arthritic ischemic optic neuropathy
Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
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.
Other Names:
  • TES
  • OkuVision
Experimental: Multiple Sclerosis
Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
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.
Other Names:
  • TES
  • OkuVision
Experimental: Ocular Trauma
Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
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.
Other Names:
  • TES
  • OkuVision
Sham Comparator: Sham - Non-arthritic ischemic optic neuropathy
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Sham
Sham Comparator: Sham - Multiple Sclerosis
Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Sham
Sham Comparator: Sham - Ocular Trauma
Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
Time Frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
The primary outcomes are change in high-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Participants read letters from a chart and receive 1 point for each letter correctly identified. Scores are converted to logMAR scale and analyzed for changes in visual acuity. Improvement in visual acuity is defined as a decrease in logMAR of 0.2 or more.
Change from Baseline (week 1) to 1-week post initial treatment (week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-Ocular Pressure (IOP)
Time Frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Measured by Applanation (Galdmann) Tonometry method
Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Visual Field Mean Deviation
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
The Humphrey 24-2 Swedish Interactive Threshold Algorithm Standard perimeter was used to test visual field. Reported values are a change from baseline to 1-week post initial treatment.
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
National Eye Institute's Visual Functioning Questionnaire - 25
Time Frame: Change from Baseline to 1 - week post initial treatment
Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
Change from Baseline to 1 - week post initial treatment
Symbol Digit Modality Testing
Time Frame: Change from Baseline to 1 - week post initial treatment
Scores range from 0-110 with higher scores meaning better visual information processing speed
Change from Baseline to 1 - week post initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Julia Haller, MD, Wills Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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