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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
Sham
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
The primary outcomes are change in high-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Participants read letters from a chart and receive 1 point for each letter correctly identified. Scores are converted to logMAR scale and analyzed for changes in visual acuity. Improvement in visual acuity is defined as a decrease in logMAR of 0.2 or more.
Time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Intra-Ocular Pressure (IOP)
Measured by Applanation (Galdmann) Tonometry method
Time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Visual Field Mean Deviation
The Humphrey 24-2 Swedish Interactive Threshold Algorithm Standard perimeter was used to test visual field. Reported values are a change from baseline to 1-week post initial treatment.
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
National Eye Institute's Visual Functioning Questionnaire - 25
Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
Time frame: Change from Baseline to 1 - week post initial treatment
Symbol Digit Modality Testing
Scores range from 0-110 with higher scores meaning better visual information processing speed
Time frame: Change from Baseline to 1 - week post initial treatment