Last reviewed · How we verify
A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
NA trial testing rtACS Stimulation in Glaucoma in 18 participants. Completed in 20 October 2022.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 14 December 2017 |
| Primary completion | 20 October 2022 |
| Estimated completion | 20 October 2022 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
Adults 50 to 70, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) measured using optical coherence tomography (OCT).
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | -0.13 | ± 2.3 |
| Sham Intervention Group | -1.8 | ± 3.91 |
Macular ganglion cell-inner plexiform layer thickness (μm) measured using OCT.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | -0.13 | ± 0.99 |
| Sham Intervention Group | 0.3 | ± 4.52 |
Percentage change in optic nerve (ON) head cup-to-disc ratio measured using OCT.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 0 | ± 0.01 |
| Sham Intervention Group | 0.01 | ± 0.01 |
The 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 0.86 | ± 6.27 |
| Sham Intervention Group | 2.89 | ± 9.65 |
The 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 0.000137 | ± 0.165273 |
| Sham Intervention Group | -0.089842 | ± 0.150235 |
An 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | -0.02857 | ± 0.108233 |
| Sham Intervention Group | 0.013333 | ± 0.074498 |
National 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 3.52 | ± 2.1405453 |
| Sham Intervention Group | 0.95 | ± 0.089 |
The 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 23.14 | ± 5.3030631 |
| Sham Intervention Group | 17.18 | ± 0.1888264 |
Visual 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 5.675 | ± 3.208632886 |
| Sham Intervention Group | 10.6655 | ± 2.1296074 |
Visual 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 119.166667 | ± 26.759733 |
| Sham Intervention Group | 130.75 | ± 19.70828929 |
Visual 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 8.3314 | ± 2.794988157 |
| Sham Intervention Group | 10.0365 | ± 3.7914384 |
Visual 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.
| Group | Value | 95% CI |
|---|---|---|
| rtACS Stimulation Group | 110.5 | ± 11.051018 |
| Sham Intervention Group | 121 | ± 10.839742 |
This pilot study will test the preliminary efficacy and feasibility of an intervention protocol for one method of electric current stimulation, repetitive transorbital alternating current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS to ameliorate the progressive effects of vision loss both structurally and functionally in the eye, the visual pathway, and in regard to people's independence (i.e., functional ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1) determine an effect of rtACS on ophthalmic structure and function (from retina to visual brain), 2) assess the methodology of procedures for assessment of people's functional ability and quality of life (QoL) to determine an effect of rtACS, and 3) assess the feasibility and implementation of the pilot study protocol for a larger multi-site, randomized controlled trial.
2 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188042.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing