Electric Stimulation of the Eye to Improve Vision After Trauma

Not Applicable

Completed

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

Interventions: Device: Transcorneal Electrical Stimulation
Device: Sham

Registration Number: NCT02019927

Lead Sponsor: Wills Eye

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 97

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-arthritic ischemic optic neuropathy	Transcorneal Electrical Stimulation	Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Sham - Ocular Trauma	Sham	Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Sham - Multiple Sclerosis	Sham	Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Multiple Sclerosis	Transcorneal Electrical Stimulation	Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Ocular Trauma	Transcorneal Electrical Stimulation	Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Sham - Non-arthritic ischemic optic neuropathy	Sham	Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant	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
Intra-Ocular Pressure (IOP)	Change from Baseline (week 1) to 1-week post initial treatment (week 8)	Measured by Applanation (Galdmann) Tonometry method
Visual Field Mean Deviation	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.
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant	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
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant	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
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant	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
Symbol Digit Modality Testing	Change from Baseline to 1 - week post initial treatment	Scores range from 0-110 with higher scores meaning better visual information processing speed
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant	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
National Eye Institute's Visual Functioning Questionnaire - 25	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