Electric Stimulation of the Eye to Improve Vision After Trauma

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Transcorneal Electrical Stimulation
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-arthritic ischemic optic neuropathy<br>Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). | Device: Transcorneal Electrical Stimulation<br>* 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.<br>* Other names: OkuVision;|
| Experimental: Multiple Sclerosis<br>Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). | Device: Transcorneal Electrical Stimulation<br>* 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.<br>* Other names: OkuVision;|
| Experimental: Ocular Trauma<br>Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). | Device: Transcorneal Electrical Stimulation<br>* 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.<br>* Other names: OkuVision;|
| Sham Comparator: Sham - Non-arthritic ischemic optic neuropathy<br>Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). | Device: Sham<br>* Sham<br>|
| Sham Comparator: Sham - Multiple Sclerosis<br>Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). | Device: Sham<br>* Sham<br>|
| Sham Comparator: Sham - Ocular Trauma<br>Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). | Device: Sham<br>* Sham<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | Measured by Applanation (Galdmann) Tonometry method | Change from Baseline (week 1) to 1-week post initial treatment (week 8) | 
| 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. | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) | 
| 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 | Change from Baseline to 1 - week post initial treatment | 
| Symbol Digit Modality Testing | Scores range from 0-110 with higher scores meaning better visual information processing speed | Change from Baseline to 1 - week post initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TES, Multiple Sclerosis, NAION, Decreased vision, Eye trauma, Electrical stimulation, Optic Neuritis