Electric Stimulation of the Eye to Improve Vision After Trauma
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Transcorneal Electrical Stimulation
Placebo
- Sham
Results by group
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)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Non-arteritic Ischemic Optic Neuropathy | -0.23 logMAR | -0.3–-0.17 | 46 |
| Sham - Non-arteritic Ischemic Optic Neuropathy | -0.14 logMAR | -0.23–-0.05 | 23 |
| Multiple Sclerosis | -0.08 logMAR | -0.22–0.06 | 9 |
| Sham - Multiple Sclerosis | -0.06 logMAR | -0.25–0.13 | 5 |
| Ocular Trauma | -0.29 logMAR | -0.45–-0.12 | 10 |
| Sham - Ocular Trauma | -0.05 logMAR | -0.3–0.2 | 4 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Non-arteritic Ischemic Optic Neuropathy | 45 | 0 (0.0%) | 0 |
| Sham - Non-arteritic Ischemic Optic Neuropathy | 23 | 0 (0.0%) | 0 |
| Multiple Sclerosis | 9 | 0 (0.0%) | 0 |
| Sham - Multiple Sclerosis | 5 | 0 (0.0%) | 0 |
| Ocular Trauma | 9 | 0 (0.0%) | 0 |
| Sham - Ocular Trauma | 4 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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)
VisionSafety
Other measures (9)
Intra-Ocular Pressure (IOP)
Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Visual Field Mean Deviation
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Retina scans (OCT)Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Retina scans (OCT)Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Retina scans (OCT)Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Retina scans (OCT)Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Retina scans (OCT)National Eye Institute's Visual Functioning Questionnaire - 25
Change from Baseline to 1 - week post initial treatment
VisionSymbol Digit Modality Testing
Change from Baseline to 1 - week post initial treatment
Thinking and memory
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jul 2013
Main results due
Sept 2017
Finished
Sept 2017
Results posted
Jan 2020