N/A
N=97
Electric Stimulation of the Eye to Improve Vision After Trauma
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) · Trauma · Multiple Sclerosis (MS)
Bottom Line
View on ClinicalTrials.gov: NCT02019927 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity — -0.23; -0.14; -0.08; -0.06 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcorneal Electrical Stimulation (Device); Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity |
-0.23; -0.14; -0.08; -0.06; -0.29; -0.05 | — |
| SECONDARY Intra-Ocular Pressure (IOP) |
-0.32; -1.13; -0.27; 0.52; 0.52; -0.57 | — |
| SECONDARY Visual Field Mean Deviation |
1.49; 2.09; 1.31; 0.96; 1.70; 0.25 | — |
| SECONDARY Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant |
-0.70; 12.41; -3.80; -5.97; 0.37; 1.42 | — |
| SECONDARY Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant |
-0.48; -1.24; -3.60; 0.28; 0.49; -1.36 | — |
| SECONDARY Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant |
-0.04; -0.64; -2.37; 1.07; 0.57; -1.53 | — |
| SECONDARY Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant |
2.15; -0.64; -0.49; 1.07; -0.35; -1.53 | — |
| SECONDARY Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant |
-0.07; 3.89; -2.83; -1.07; -0.62; -0.42 | — |
| SECONDARY National Eye Institute's Visual Functioning Questionnaire - 25 |
-0.59; 0.16; 4.59; 4.57; 3.64; 5.27 | — |
| SECONDARY Symbol Digit Modality Testing |
-0.03; -0.01; 2.98; -0.77; 4.08; 6.14 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02019927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.