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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-arthritic ischemic optic neuropathy | Experimental | Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). |
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| Multiple Sclerosis | Experimental | Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). |
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| Ocular Trauma | Experimental | Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). |
|
| Sham - Non-arthritic ischemic optic neuropathy | Sham Comparator | Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). |
|
| Sham - Multiple Sclerosis | Sham Comparator | Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcorneal Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline (week 1) to 1-week post initial treatment (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-Ocular Pressure (IOP) | Measured by Applanation (Galdmann) Tonometry method | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Haller, MD | Wills Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-arteritic Ischemic Optic Neuropathy | Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). Transcorneal Electrical Stimulation: 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. |
| FG001 | Non-arteritic Ischemic Optic Neuropathy (NAION) Sham | Sham treatment for Non-arteritic ischemic optic neuropathy group |
| FG002 | Multiple Sclerosis | Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). Transcorneal Electrical Stimulation: 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. |
| FG003 | Multiple Sclerosis Sham | Sham treatment for optic neuritis with Multiple Sclerosis group |
| FG004 | Ocular Trauma | Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). Transcorneal Electrical Stimulation: 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. |
| FG005 | Ocular Trauma Sham | Sham treatment for ocular trauma group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-arteritic Ischemic Optic Neuropathy | Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). Transcorneal Electrical Stimulation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | logMAR | Change from Baseline (week 1) to 1-week post initial treatment (week 8) |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-arteritic Ischemic Optic Neuropathy | Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). Transcorneal Electrical Stimulation: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor ocular surface irritation | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Murchison MD | Will Eye Hopsital | 267-733-9617 | Visionresearch@willseye.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Sep 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009103 | Multiple Sclerosis |
| D018917 | Optic Neuropathy, Ischemic |
| D014786 | Vision Disorders |
| D005131 | Eye Injuries |
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Sham - Ocular Trauma | Sham Comparator | Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). |
|
|
|
| Sham | Device | Sham |
|
| 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 | 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 | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
| Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant | Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline | 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 | 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 | 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 | 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 | Change from Baseline to 1 - week post initial treatment |
| BG001 | Non-arteritic Ischemic Optic Neuropathy Sham | Sham comparator for the Non-arteritic ischemic optic neuropathy group |
| BG002 | Multiple Sclerosis | Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). Transcorneal Electrical Stimulation: 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. |
| BG003 | Multiple Sclerosis Sham | Sham comparator for the multiple sclerosis group |
| BG004 | Ocular Trauma | Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). Transcorneal Electrical Stimulation: 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. |
| BG005 | Ocular Trauma Sham | Sham comparator for the ocular trauma group |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham - Non-arteritic Ischemic Optic Neuropathy | Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). |
| OG002 | Multiple Sclerosis | Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). Transcorneal Electrical Stimulation: 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. |
| OG003 | Sham - Multiple Sclerosis | Sham treatment of decreased vision due to Multiple Sclerosis |
| OG004 | Ocular Trauma | Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). Transcorneal Electrical Stimulation: 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. |
| OG005 | Sham - Ocular Trauma | Sham treatment of decreased vision due to ocular trauma |
|
|
| Secondary | Intra-Ocular Pressure (IOP) | Measured by Applanation (Galdmann) Tonometry method | Posted | Mean | 95% Confidence Interval | mmHg | Change from Baseline (week 1) to 1-week post initial treatment (week 8) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Decibels (dB) | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | um | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | um | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant | Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline | Posted | Mean | 95% Confidence Interval | um | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | um | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | um | Change from Baseline (week 1) to 1 - week post initial treatment (week 8) |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale - change from baseline | Change from Baseline to 1 - week post initial treatment |
|
|
|
| Secondary | Symbol Digit Modality Testing | Scores range from 0-110 with higher scores meaning better visual information processing speed | Posted | Mean | 95% Confidence Interval | score on a scale - change from baseline | Change from Baseline to 1 - week post initial treatment |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 15 |
| 45 |
| EG001 | Sham - Non-arteritic Ischemic Optic Neuropathy | Sham treatment of decreased vision due to NAION | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Multiple Sclerosis | Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). Transcorneal Electrical Stimulation: 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. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG003 | Sham - Multiple Sclerosis | Sham treatment of decreased vision due to Multiple Sclerosis | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Ocular Trauma | Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). Transcorneal Electrical Stimulation: 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. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG005 | Sham - Ocular Trauma | Sham treatment of decreased vision due to ocular trauma | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |