- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02019927
Electric Stimulation of the Eye to Improve Vision After Trauma (TES)
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-arthritic ischemic optic neuropathy
Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
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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.
Other Names:
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Experimental: Multiple Sclerosis
Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
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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.
Other Names:
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Experimental: Ocular Trauma
Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
|
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.
Other Names:
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Sham Comparator: Sham - Non-arthritic ischemic optic neuropathy
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
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Sham
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Sham Comparator: Sham - Multiple Sclerosis
Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
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Sham
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Sham Comparator: Sham - Ocular Trauma
Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
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Sham
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
Time Frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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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.
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Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-Ocular Pressure (IOP)
Time Frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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Measured by Applanation (Galdmann) Tonometry method
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Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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Visual Field Mean Deviation
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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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.
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Time Frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
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Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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National Eye Institute's Visual Functioning Questionnaire - 25
Time Frame: Change from Baseline to 1 - week post initial treatment
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Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
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Change from Baseline to 1 - week post initial treatment
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Symbol Digit Modality Testing
Time Frame: Change from Baseline to 1 - week post initial treatment
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Scores range from 0-110 with higher scores meaning better visual information processing speed
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Change from Baseline to 1 - week post initial treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Haller, MD, Wills Eye Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Cranial Nerve Diseases
- Multiple Sclerosis
- Sclerosis
- Wounds and Injuries
- Optic Nerve Diseases
- Optic Neuropathy, Ischemic
Other Study ID Numbers
- 12-232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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