TES: Electric Stimulation of the Eye to Improve Vision After Trauma
Sponsor
Wills Eye (Other)
Overall Status
Completed
CT.gov ID
NCT02019927
Collaborator
United States Department of Defense (U.S. Fed)
97
1
6
50
1.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
Study Start Date
:
Jul 1, 2013
Actual Primary Completion Date
:
Sep 1, 2017
Actual Study Completion Date
:
Sep 1, 2017
Arms and Interventions
| 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). |
Device: 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.
Other Names:
|
| Experimental: Multiple Sclerosis Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes). |
Device: 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.
Other Names:
|
| Experimental: Ocular Trauma Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). |
Device: 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.
Other Names:
|
| 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). |
Device: Sham
Sham
|
| 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). |
Device: Sham
Sham
|
| Sham Comparator: Sham - Ocular Trauma Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma). |
Device: Sham
Sham
|
Outcome Measures
Primary Outcome 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)]
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.
Secondary Outcome Measures
- Intra-Ocular Pressure (IOP) [Change from Baseline (week 1) to 1-week post initial treatment (week 8)]
Measured by Applanation (Galdmann) Tonometry method
- Visual Field Mean Deviation [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
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.
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
- Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant [Change from Baseline (week 1) to 1 - week post initial treatment (week 8)]
Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline
- National Eye Institute's Visual Functioning Questionnaire - 25 [Change from Baseline to 1 - week post initial treatment]
Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
- Symbol Digit Modality Testing [Change from Baseline to 1 - week post initial treatment]
Scores range from 0-110 with higher scores meaning better visual information processing speed
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wills Eye Hospital | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Wills Eye
- United States Department of Defense
Investigators
- Principal Investigator: Julia Haller, MD, Wills Eye Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Julia Haller,
Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma,
Wills Eye
ClinicalTrials.gov Identifier:
NCT02019927
Other Study ID Numbers:
- 12-232
First Posted:
Dec 24, 2013
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Julia Haller,
Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma,
Wills Eye
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Non-arteritic Ischemic Optic Neuropathy (NAION) Sham | Multiple Sclerosis | Multiple Sclerosis Sham | Ocular Trauma | Ocular Trauma Sham |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment for Non-arteritic ischemic optic neuropathy group | 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. | Sham treatment for optic neuritis with Multiple Sclerosis group | 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. | Sham treatment for ocular trauma group |
| Period Title: Overall Study | ||||||
| STARTED | 46 | 23 | 9 | 5 | 10 | 4 |
| COMPLETED | 44 | 19 | 8 | 3 | 7 | 3 |
| NOT COMPLETED | 2 | 4 | 1 | 2 | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Non-arteritic Ischemic Optic Neuropathy Sham | Multiple Sclerosis | Multiple Sclerosis Sham | Ocular Trauma | Ocular Trauma Sham | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham comparator for the Non-arteritic ischemic optic neuropathy group | 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. | Sham comparator for the multiple sclerosis group | 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. | Sham comparator for the ocular trauma group | Total of all reporting groups |
| Overall Participants | 46 | 23 | 9 | 5 | 10 | 4 | 97 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
62.6
(8.8)
|
66
(7.4)
|
40.6
(9.7)
|
41
(9.2)
|
49.2
(14.2)
|
45.5
(13.2)
|
50.8
(10.9)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
13
28.3%
|
11
47.8%
|
7
77.8%
|
3
60%
|
2
20%
|
1
25%
|
37
38.1%
|
| Male |
33
71.7%
|
12
52.2%
|
2
22.2%
|
2
40%
|
8
80%
|
3
75%
|
60
61.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1%
|
| Not Hispanic or Latino |
44
95.7%
|
23
100%
|
9
100%
|
5
100%
|
8
80%
|
4
100%
|
93
95.9%
|
| Unknown or Not Reported |
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
2
20%
|
0
0%
|
3
3.1%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
2.2%
|
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
2
2.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
2.2%
|
2
8.7%
|
1
11.1%
|
2
40%
|
0
0%
|
0
0%
|
6
6.2%
|
| White |
43
93.5%
|
21
91.3%
|
7
77.8%
|
3
60%
|
8
80%
|
4
100%
|
86
88.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
2
20%
|
0
0%
|
3
3.1%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
46
100%
|
23
100%
|
9
100%
|
5
100%
|
10
100%
|
4
100%
|
97
100%
|
Outcome Measures
| Title | Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). | 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. | Sham treatment of decreased vision due to Multiple Sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 46 | 23 | 9 | 5 | 10 | 4 |
| Mean (95% Confidence Interval) [logMAR] |
-0.23
|
-0.14
|
-0.08
|
-0.06
|
-0.29
|
-0.05
|
| Title | Intra-Ocular Pressure (IOP) |
|---|---|
| Description | Measured by Applanation (Galdmann) Tonometry method |
| Time Frame | Change from Baseline (week 1) to 1-week post initial treatment (week 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy (NAION) | Multiple Sclerosis | Sham - Multiple Sclerosis (MS) | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to MS | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 41 | 21 | 6 | 5 | 8 | 2 |
| Mean (95% Confidence Interval) [mmHg] |
-0.32
|
-1.13
|
-0.27
|
0.52
|
0.52
|
-0.57
|
| Title | Visual Field Mean Deviation |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 44 | 23 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [Decibels (dB)] |
1.49
|
2.09
|
1.31
|
0.96
|
1.70
|
0.25
|
| Title | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 42 | 21 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [um] |
-0.70
|
12.41
|
-3.80
|
-5.97
|
0.37
|
1.42
|
| Title | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 42 | 21 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [um] |
-0.48
|
-1.24
|
-3.60
|
0.28
|
0.49
|
-1.36
|
| Title | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 42 | 21 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [um] |
-0.04
|
-0.64
|
-2.37
|
1.07
|
0.57
|
-1.53
|
| Title | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 42 | 21 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [um] |
2.15
|
-0.64
|
-0.49
|
1.07
|
-0.35
|
-1.53
|
| Title | Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 37 | 22 | 8 | 5 | 7 | 4 |
| Mean (95% Confidence Interval) [um] |
-0.07
|
3.89
|
-2.83
|
-1.07
|
-0.62
|
-0.42
|
| Title | National Eye Institute's Visual Functioning Questionnaire - 25 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 45 | 23 | 9 | 5 | 9 | 4 |
| Mean (95% Confidence Interval) [score on a scale - change from baseline] |
-0.59
|
0.16
|
4.59
|
4.57
|
3.64
|
5.27
|
| Title | Symbol Digit Modality Testing |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - NAION | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma |
|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to multiple sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma |
| Measure Participants | 30 | 14 | 7 | 5 | 7 | 3 |
| Mean (95% Confidence Interval) [score on a scale - change from baseline] |
-0.03
|
-0.01
|
2.98
|
-0.77
|
4.08
|
6.14
|
Adverse Events
| Time Frame | 3 years | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma | ||||||
| Arm/Group Description | 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. | Sham treatment of decreased vision due to NAION | 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. | Sham treatment of decreased vision due to Multiple Sclerosis | 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. | Sham treatment of decreased vision due to ocular trauma | ||||||
All Cause Mortality |
||||||||||||
| Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/23 (0%) | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/4 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/23 (0%) | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/4 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Non-arteritic Ischemic Optic Neuropathy | Sham - Non-arteritic Ischemic Optic Neuropathy | Multiple Sclerosis | Sham - Multiple Sclerosis | Ocular Trauma | Sham - Ocular Trauma | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/45 (33.3%) | 0/23 (0%) | 3/9 (33.3%) | 0/5 (0%) | 5/9 (55.6%) | 0/4 (0%) | ||||||
| Eye disorders | ||||||||||||
| Minor ocular surface irritation | 15/45 (33.3%) | 15 | 0/23 (0%) | 0 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 5/9 (55.6%) | 5 | 0/4 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ann Murchison MD |
|---|---|
| Organization | Will Eye Hopsital |
| Phone | 267-733-9617 |
| Visionresearch@willseye.org |
Responsible Party:
Julia Haller,
Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma,
Wills Eye
ClinicalTrials.gov Identifier:
NCT02019927
Other Study ID Numbers:
- 12-232
First Posted:
Dec 24, 2013
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020