Clinical trial NCT02019927: Electric Stimulation of the Eye to Improve Vision After Trauma
Official title: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Trauma
Multiple Sclerosis (MS)
Keywords: NAION
Decreased vision
Eye trauma
TES
Electrical stimulation
Multiple Sclerosis
Optic Neuritis
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-12-24
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
timeFrame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Secondary outcomes:
measure: Intra-Ocular Pressure (IOP)
timeFrame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
measure: Visual Field Mean Deviation
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
timeFrame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
measure: National Eye Institute's Visual Functioning Questionnaire - 25
timeFrame: Change from Baseline to 1 - week post initial treatment
measure: Symbol Digit Modality Testing
timeFrame: Change from Baseline to 1 - week post initial treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Julia Haller, MD
role: PRINCIPAL_INVESTIGATOR
References: