Trial Outcomes & Findings for Electric Stimulation of the Eye to Improve Vision After Trauma (NCT NCT02019927)
NCT ID: NCT02019927
Last Updated: 2020-01-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
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.
|
Non-arteritic Ischemic Optic Neuropathy (NAION) Sham
Sham treatment for Non-arteritic ischemic optic neuropathy group
|
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.
|
Multiple Sclerosis Sham
Sham treatment for optic neuritis with Multiple Sclerosis group
|
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.
|
Ocular Trauma Sham
Sham treatment for ocular trauma group
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
23
|
9
|
5
|
10
|
4
|
|
Overall Study
COMPLETED
|
44
|
19
|
8
|
3
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Non-arteritic Ischemic Optic Neuropathy (NAION) Sham
Sham treatment for Non-arteritic ischemic optic neuropathy group
|
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.
|
Multiple Sclerosis Sham
Sham treatment for optic neuritis with Multiple Sclerosis group
|
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.
|
Ocular Trauma Sham
Sham treatment for ocular trauma group
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
1
|
2
|
3
|
1
|
Baseline Characteristics
Electric Stimulation of the Eye to Improve Vision After Trauma
Baseline characteristics by cohort
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=46 Participants
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.
|
Non-arteritic Ischemic Optic Neuropathy Sham
n=23 Participants
Sham comparator for the Non-arteritic ischemic optic neuropathy group
|
Multiple Sclerosis
n=9 Participants
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.
|
Multiple Sclerosis Sham
n=5 Participants
Sham comparator for the multiple sclerosis group
|
Ocular Trauma
n=10 Participants
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.
|
Ocular Trauma Sham
n=4 Participants
Sham comparator for the ocular trauma group
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
66 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
41 years
STANDARD_DEVIATION 9.2 • n=483 Participants
|
49.2 years
STANDARD_DEVIATION 14.2 • n=36 Participants
|
45.5 years
STANDARD_DEVIATION 13.2 • n=10 Participants
|
50.8 years
STANDARD_DEVIATION 10.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
93 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
86 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
23 participants
n=4 Participants
|
9 participants
n=27 Participants
|
5 participants
n=483 Participants
|
10 participants
n=36 Participants
|
4 participants
n=10 Participants
|
97 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=46 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=23 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=10 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
|
-0.23 logMAR
Interval -0.3 to -0.17
|
-0.14 logMAR
Interval -0.23 to -0.05
|
-0.08 logMAR
Interval -0.22 to 0.06
|
-0.06 logMAR
Interval -0.25 to 0.13
|
-0.29 logMAR
Interval -0.45 to -0.12
|
-0.05 logMAR
Interval -0.3 to 0.2
|
SECONDARY outcome
Timeframe: Change from Baseline (week 1) to 1-week post initial treatment (week 8)Measured by Applanation (Galdmann) Tonometry method
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=41 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=21 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=6 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=8 Participants
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 - Ocular Trauma
n=2 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Intra-Ocular Pressure (IOP)
|
-0.32 mmHg
Interval -0.99 to 0.34
|
-1.13 mmHg
Interval -2.06 to -0.2
|
-0.27 mmHg
Interval -3.26 to 2.72
|
0.52 mmHg
Interval -2.77 to 3.81
|
0.52 mmHg
Interval -1.57 to 2.6
|
-0.57 mmHg
Interval -4.78 to 3.63
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=44 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=23 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Visual Field Mean Deviation
|
1.49 Decibels (dB)
Interval 0.72 to 2.25
|
2.09 Decibels (dB)
Interval 1.03 to 3.15
|
1.31 Decibels (dB)
Interval -0.94 to 3.55
|
0.96 Decibels (dB)
Interval -2.21 to 4.13
|
1.70 Decibels (dB)
Interval 0.23 to 3.18
|
0.25 Decibels (dB)
Interval -1.98 to 2.48
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=42 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=21 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
|
-0.70 um
Interval -9.92 to 8.52
|
12.41 um
Interval -0.66 to 25.47
|
-3.80 um
Interval -12.97 to 5.37
|
-5.97 um
Interval -18.86 to 6.92
|
0.37 um
Interval -2.13 to 2.87
|
1.42 um
Interval -2.33 to 5.17
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=42 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=21 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
|
-0.48 um
Interval -2.64 to 1.69
|
-1.24 um
Interval -4.3 to 1.82
|
-3.60 um
Interval -9.33 to 2.12
|
0.28 um
Interval -7.69 to 8.26
|
0.49 um
Interval -1.66 to 2.65
|
-1.36 um
Interval -4.59 to 1.88
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=42 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=21 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
|
-0.04 um
Interval -1.28 to 1.21
|
-0.64 um
Interval -2.4 to 1.12
|
-2.37 um
Interval -6.94 to 2.19
|
1.07 um
Interval -5.23 to 7.37
|
0.57 um
Interval -2.03 to 3.16
|
-1.53 um
Interval -5.51 to 2.46
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=42 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=21 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
|
2.15 um
Interval -2.43 to 6.73
|
-0.64 um
Interval -2.4 to 1.12
|
-0.49 um
Interval -1.62 to 0.64
|
1.07 um
Interval -5.23 to 7.37
|
-0.35 um
Interval -1.71 to 1.0
|
-1.53 um
Interval -5.51 to 2.46
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=37 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=22 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=8 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=7 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
|
-0.07 um
Interval -4.43 to 4.23
|
3.89 um
Interval -1.79 to 9.55
|
-2.83 um
Interval -7.63 to 1.97
|
-1.07 um
Interval -7.34 to 5.19
|
-0.62 um
Interval -2.14 to 0.91
|
-0.42 um
Interval -2.5 to 1.66
|
SECONDARY outcome
Timeframe: Change from Baseline to 1 - week post initial treatmentTest to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=45 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=23 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=9 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 Participants
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 - Ocular Trauma
n=4 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
National Eye Institute's Visual Functioning Questionnaire - 25
|
-0.59 score on a scale - change from baseline
Interval -2.41 to 1.24
|
0.16 score on a scale - change from baseline
Interval -2.4 to 2.72
|
4.59 score on a scale - change from baseline
Interval -2.55 to 11.73
|
4.57 score on a scale - change from baseline
Interval -5.08 to 14.22
|
3.64 score on a scale - change from baseline
Interval -1.4 to 8.67
|
5.27 score on a scale - change from baseline
Interval -2.51 to 13.04
|
SECONDARY outcome
Timeframe: Change from Baseline to 1 - week post initial treatmentScores range from 0-110 with higher scores meaning better visual information processing speed
Outcome measures
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=30 Participants
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 - Non-arteritic Ischemic Optic Neuropathy
n=14 Participants
Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
|
Multiple Sclerosis
n=7 Participants
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 - Multiple Sclerosis
n=5 Participants
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=7 Participants
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 - Ocular Trauma
n=3 Participants
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Symbol Digit Modality Testing
|
-0.03 score on a scale - change from baseline
Interval -2.42 to 2.37
|
-0.01 score on a scale - change from baseline
Interval -3.52 to 3.5
|
2.98 score on a scale - change from baseline
Interval -1.7 to 7.66
|
-0.77 score on a scale - change from baseline
Interval -6.48 to 4.94
|
4.08 score on a scale - change from baseline
Interval -2.19 to 10.36
|
6.14 score on a scale - change from baseline
Interval -3.58 to 15.86
|
Adverse Events
Non-arteritic Ischemic Optic Neuropathy
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Sham - Non-arteritic Ischemic Optic Neuropathy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple Sclerosis
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham - Multiple Sclerosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ocular Trauma
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham - Ocular Trauma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-arteritic Ischemic Optic Neuropathy
n=45 participants at risk
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 - Non-arteritic Ischemic Optic Neuropathy
n=23 participants at risk
Sham treatment of decreased vision due to NAION
|
Multiple Sclerosis
n=9 participants at risk
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 - Multiple Sclerosis
n=5 participants at risk
Sham treatment of decreased vision due to Multiple Sclerosis
|
Ocular Trauma
n=9 participants at risk
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 - Ocular Trauma
n=4 participants at risk
Sham treatment of decreased vision due to ocular trauma
|
|---|---|---|---|---|---|---|
|
Eye disorders
Minor ocular surface irritation
|
33.3%
15/45 • Number of events 15 • 3 years
|
0.00%
0/23 • 3 years
|
33.3%
3/9 • Number of events 3 • 3 years
|
0.00%
0/5 • 3 years
|
55.6%
5/9 • Number of events 5 • 3 years
|
0.00%
0/4 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place