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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcorneal Electrical Stimulation
Sham
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) focused on measuring NAION, Decreased vision, Eye trauma, TES, Electrical stimulation, Multiple Sclerosis, Optic Neuritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wills Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Sham Comparator

Sham Comparator

Arm Label

Non-arthritic ischemic optic neuropathy

Multiple Sclerosis

Ocular Trauma

Sham - Non-arthritic ischemic optic neuropathy

Sham - Multiple Sclerosis

Sham - Ocular Trauma

Arm Description

Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).

Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).

Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).

Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).

Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).

Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).

Outcomes

Primary Outcome Measures

Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
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.

Secondary Outcome Measures

Intra-Ocular Pressure (IOP)
Measured by Applanation (Galdmann) Tonometry method
Visual Field Mean Deviation
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.
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
National Eye Institute's Visual Functioning Questionnaire - 25
Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
Symbol Digit Modality Testing
Scores range from 0-110 with higher scores meaning better visual information processing speed

Full Information

First Posted
December 18, 2013
Last Updated
January 6, 2020
Sponsor
Wills Eye
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02019927
Brief Title
Electric Stimulation of the Eye to Improve Vision After Trauma
Acronym
TES
Official Title
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), Trauma, Multiple Sclerosis (MS)
Keywords
NAION, Decreased vision, Eye trauma, TES, Electrical stimulation, Multiple Sclerosis, Optic Neuritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-arthritic ischemic optic neuropathy
Arm Type
Experimental
Arm Description
Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Arm Title
Multiple Sclerosis
Arm Type
Experimental
Arm Description
Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Arm Title
Ocular Trauma
Arm Type
Experimental
Arm Description
Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Arm Title
Sham - Non-arthritic ischemic optic neuropathy
Arm Type
Sham Comparator
Arm Description
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Arm Title
Sham - Multiple Sclerosis
Arm Type
Sham Comparator
Arm Description
Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Arm Title
Sham - Ocular Trauma
Arm Type
Sham Comparator
Arm Description
Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Intervention Type
Device
Intervention Name(s)
Transcorneal Electrical Stimulation
Other Intervention Name(s)
TES, OkuVision
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
Description
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.
Time Frame
Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Secondary Outcome Measure Information:
Title
Intra-Ocular Pressure (IOP)
Description
Measured by Applanation (Galdmann) Tonometry method
Time Frame
Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Title
Visual Field Mean Deviation
Description
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.
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Description
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Description
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Description
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Description
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Description
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time Frame
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Title
National Eye Institute's Visual Functioning Questionnaire - 25
Description
Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
Time Frame
Change from Baseline to 1 - week post initial treatment
Title
Symbol Digit Modality Testing
Description
Scores range from 0-110 with higher scores meaning better visual information processing speed
Time Frame
Change from Baseline to 1 - week post initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Haller, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Electric Stimulation of the Eye to Improve Vision After Trauma

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