Electric Stimulation of the Eye to Improve Vision After Trauma (TES)
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), Trauma, Multiple Sclerosis (MS)
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
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
Experimental
Experimental
Experimental
Sham Comparator
Sham Comparator
Sham Comparator
Non-arthritic ischemic optic neuropathy
Multiple Sclerosis
Ocular Trauma
Sham - Non-arthritic ischemic optic neuropathy
Sham - Multiple Sclerosis
Sham - Ocular Trauma
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).