Trial Outcomes & Findings for A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma (NCT NCT03188042)
NCT ID: NCT03188042
Last Updated: 2024-02-09
Results Overview
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) measured using optical coherence tomography (OCT).
COMPLETED
NA
18 participants
Baseline, Week 4
2024-02-09
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
rtACS Stimulation Group
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Overall Study
STARTED
|
8 16
|
10 20
|
|
Overall Study
COMPLETED
|
7 14
|
9 18
|
|
Overall Study
NOT COMPLETED
|
1 2
|
1 2
|
Reasons for withdrawal
| Measure |
rtACS Stimulation Group
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
Baseline characteristics by cohort
| Measure |
rtACS Stimulation Group
n=7 Participants
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=9 Participants
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
59 years
STANDARD_DEVIATION 20 • n=7 Participants
|
61 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) measured using optical coherence tomography (OCT).
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Peripapillary RNFL Thickness
|
-0.13 micrometers (μm)
Standard Deviation 2.3
|
-1.8 micrometers (μm)
Standard Deviation 3.91
|
PRIMARY outcome
Timeframe: Baseline, Week 4Macular ganglion cell-inner plexiform layer thickness (μm) measured using OCT.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Macular Ganglion Cell-Inner Plexiform Layer Thickness
|
-0.13 micrometers (μm)
Standard Deviation 0.99
|
0.3 micrometers (μm)
Standard Deviation 4.52
|
PRIMARY outcome
Timeframe: Baseline, Week 4Percentage change in optic nerve (ON) head cup-to-disc ratio measured using OCT.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Percentage Change in ON Head Cup-to-Disc Ratio
|
0 percentage (%) change
Standard Deviation 0.01
|
0.01 percentage (%) change
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Baseline, Week 4The Humphrey Visual Field Analyzer assesses the mean deviation (dB), a measure of visual field sensitivity through threshold testing. dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen. Most values are around 30 dB, and any numbers below this range imply a possible visual field defect.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Humphrey Visual Field Analyzer Score
|
0.86 dB
Standard Deviation 6.27
|
2.89 dB
Standard Deviation 9.65
|
PRIMARY outcome
Timeframe: Baseline, Week 4The LIFE-H short form 3.1 is a 77-item questionnaire developed to measure: (1) how a respondent accomplishes regular activities and social roles and (2) respondent's satisfaction with how regular activities and social roles are accomplished. The LIFE-H total score is obtained by summing the scores on each item and then dividing by the number of items. The LIFE-H score ranges from 0 to 9, where a score of 0 indicates total handicap or total disruption in participation and a score of 9 means an optimal level of participation.
Outcome measures
| Measure |
rtACS Stimulation Group
n=7 Participants
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=9 Participants
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Score on Assessment of Life Habits (LIFE-H), Short Form 3.1
|
0.000137 score on a scale
Standard Error 0.165273
|
-0.089842 score on a scale
Standard Error 0.150235
|
PRIMARY outcome
Timeframe: Baseline, Week 4An estimate of reading acuity is given by the smallest print size at which the patient can read the entire sentence without making significant errors. This method measures acuity to the nearest 0.1 logMAR. Each sentence in the MNRead Reading Acuity chart has 60 characters, which corresponds to 10 standard length words, assuming a standard word length of 6 characters (including a space). Reading acuity is calculated as follows: Reading acuity = size of smallest sentence read + 0.01 x number of errors.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Minnesota Low Vision Reading Test (MNRead): Reading Acuity Score
|
-0.02857 logMAR
Standard Deviation 0.108233
|
0.013333 logMAR
Standard Deviation 0.074498
|
PRIMARY outcome
Timeframe: Baseline, Week 4National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. The total score is the average of the domain scores.
Outcome measures
| Measure |
rtACS Stimulation Group
n=7 Participants
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=9 Participants
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Score on National Eye Institute Visual Functioning Questionnaire (VFQ-39)
|
3.52 score on a scale
Standard Error 2.1405453
|
0.95 score on a scale
Standard Error 0.089
|
PRIMARY outcome
Timeframe: Baseline, Week 4The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. The total score is the average of the domain scores.
Outcome measures
| Measure |
rtACS Stimulation Group
n=7 Participants
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=9 Participants
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Change in Score on 36-Item Short Form Survey (SF-36)
|
23.14 score on a scale
Standard Error 5.3030631
|
17.18 score on a scale
Standard Error 0.1888264
|
PRIMARY outcome
Timeframe: BaselineVisual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=6 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=8 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Amplitude (15% Contrast) at Baseline
|
5.675 micro volts
Standard Deviation 3.208632886
|
10.6655 micro volts
Standard Deviation 2.1296074
|
PRIMARY outcome
Timeframe: BaselineVisual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=6 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=8 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Latency (15% Contrast) at Baseline
|
119.166667 milliseconds
Standard Deviation 26.759733
|
130.75 milliseconds
Standard Deviation 19.70828929
|
PRIMARY outcome
Timeframe: BaselineVisual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=10 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=12 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Amplitude (85% Contrast) at Baseline
|
8.3314 micro volts
Standard Deviation 2.794988157
|
10.0365 micro volts
Standard Deviation 3.7914384
|
PRIMARY outcome
Timeframe: BaselineVisual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=10 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=12 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Latency (85% Contrast) at Baseline
|
110.5 milliseconds
Standard Deviation 11.051018
|
121 milliseconds
Standard Deviation 10.839742
|
PRIMARY outcome
Timeframe: Week 4Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=8 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=10 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Amplitude (15% Contrast) at Week 4
|
6.62025 micro volts
Standard Deviation 0.905566995
|
7.1814 micro volts
Standard Deviation 2.865013
|
PRIMARY outcome
Timeframe: Week 4Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=8 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=10 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Latency (15% Contrast) at Week 4
|
119.25 milliseconds
Standard Deviation 11.97566978
|
131.7 milliseconds
Standard Deviation 14.267971
|
PRIMARY outcome
Timeframe: Week 4Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=12 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=10 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Amplitude (85% Contrast) at Week 4
|
8.4108333 micro volts
Standard Deviation 4.3606635
|
9.8224 micro volts
Standard Deviation 2.8729446
|
PRIMARY outcome
Timeframe: Week 4Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Outcome measures
| Measure |
rtACS Stimulation Group
n=12 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=10 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
VEP-Measured Latency (85% Contrast) at Week 4
|
119.4166667 milliseconds
Standard Deviation 11.8634593
|
122.3 milliseconds
Standard Deviation 10.556988
|
PRIMARY outcome
Timeframe: BaselineThe Pelli-Robson test measures contrast sensitivity using a single large letter size (20/60 optotype), with contrast varying across groups of letters. The chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Patients read the letters, starting with the highest contrast, until they are unable to read two or three letters in a single group. A score is assigned based on the contrast of the last group in which two or three letters were correctly read. The score, a single number, is a measure of the subject's log contrast sensitivity. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Pelli-Robson Contrast Sensitivity Chart Score at Baseline
|
1.4 LogCS
Standard Deviation 0.42
|
1.26 LogCS
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Week 4The Pelli-Robson test measures contrast sensitivity using a single large letter size (20/60 optotype), with contrast varying across groups of letters. The chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Patients read the letters, starting with the highest contrast, until they are unable to read two or three letters in a single group. A score is assigned based on the contrast of the last group in which two or three letters were correctly read. The score, a single number, is a measure of the subject's log contrast sensitivity. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Pelli-Robson Contrast Sensitivity Chart Score at Week 4
|
1.39 LogCS
Standard Deviation 0.35
|
1.08 LogCS
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: BaselineETDRS charts have five Sloan letters on each line; the lines are of equal difficulty, and there is a geometric progression in letter size from line to line. Beginning with Chart 1, the right eye is tested with the left eye occluded. Following the completion of testing the right eye, the left eye is tested with Chart 2 while covering the right eye. Each letter is scored as right or wrong. Correct letters are circled on the scoresheet. Each letter read correctly is assigned a score and each line is totaled at the end of testing. VAS awards one point for every letter correctly guessed. The total scores range from 0 to 100, with higher scores indicating greater visual acuity.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Baseline
|
0.08 score on a scale
Standard Deviation 0.13
|
0.16 score on a scale
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Week 4ETDRS charts have five Sloan letters on each line; the lines are of equal difficulty, and there is a geometric progression in letter size from line to line. Beginning with Chart 1, the right eye is tested with the left eye occluded. Following the completion of testing the right eye, the left eye is tested with Chart 2 while covering the right eye. Each letter is scored as right or wrong. Correct letters are circled on the scoresheet. Each letter read correctly is assigned a score and each line is totaled at the end of testing. VAS awards one point for every letter correctly guessed. The total scores range from 0 to 100, with higher scores indicating greater visual acuity.
Outcome measures
| Measure |
rtACS Stimulation Group
n=14 Eyes
rtACS Stimulation: Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
Sham Intervention Group
n=18 Eyes
Sham stimulation looks like rtACS, but is not active rtACS.
Sham Intervention: A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Week 4
|
0.10 score on a scale
Standard Deviation 0.14
|
0.16 score on a scale
Standard Deviation 0.17
|
Adverse Events
rtACS Stimulation Group
Sham Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place