Electric Stimulation of the Eye to Improve Vision After Trauma (NCT02019927) | Clinical Trial Compass
CompletedNot Applicable
Electric Stimulation of the Eye to Improve Vision After Trauma
United States97 participantsStarted 2013-07
Plain-language summary
Transcorneal Electrical Stimulation (TES) using the "OkuStimĀ®" 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 oā¦
What they're measuring
1
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)