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

Wills Eye

Status: Completed

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

Treatments: Device: Transcorneal Electrical Stimulation; Device: Sham

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02019927

12-232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 6 patient groups

Non-arthritic ischemic optic neuropathy

Experimental group

Description:

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

Treatment:

Device: Transcorneal Electrical Stimulation

Multiple Sclerosis

Experimental group

Description:

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

Treatment:

Device: Transcorneal Electrical Stimulation

Ocular Trauma

Experimental group

Description:

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

Treatment:

Device: Transcorneal Electrical Stimulation

Sham - Non-arthritic ischemic optic neuropathy

Sham Comparator group

Description:

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

Treatment:

Device: Sham

Sham - Multiple Sclerosis

Sham Comparator group

Description:

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

Treatment:

Device: Sham

Sham - Ocular Trauma

Sham Comparator group

Description:

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

Treatment:

Device: Sham