N/A Completed N=18 Randomized Double-blind Treatment

A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma

Glaucoma

Source: ClinicalTrials.gov NCT03188042 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Feb 2024

Primary outcomePrimary: Change in Peripapillary RNFL Thickness — -0.13; -1.8 micrometers (μm)

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Peripapillary RNFL Thickness	-0.13; -1.8	—
PRIMARY Change in Macular Ganglion Cell-Inner Plexiform Layer Thickness	-0.13; 0.3	—
PRIMARY Percentage Change in ON Head Cup-to-Disc Ratio	0; 0.01	—
PRIMARY Change in Humphrey Visual Field Analyzer Score	0.86; 2.89	—
PRIMARY Change in Score on Assessment of Life Habits (LIFE-H), Short Form 3.1	0.000137; -0.089842	—
PRIMARY Change in Minnesota Low Vision Reading Test (MNRead): Reading Acuity Score	-0.02857; 0.013333	—
PRIMARY Change in Score on National Eye Institute Visual Functioning Questionnaire (VFQ-39)	3.52; 0.95	—
PRIMARY Change in Score on 36-Item Short Form Survey (SF-36)	23.14; 17.18	—
PRIMARY VEP-Measured Amplitude (15% Contrast) at Baseline	5.675; 10.6655	—
PRIMARY VEP-Measured Latency (15% Contrast) at Baseline	119.166667; 130.75	—
PRIMARY VEP-Measured Amplitude (85% Contrast) at Baseline	8.3314; 10.0365	—
PRIMARY VEP-Measured Latency (85% Contrast) at Baseline	110.5; 121	—
PRIMARY VEP-Measured Amplitude (15% Contrast) at Week 4	6.62025; 7.1814	—
PRIMARY VEP-Measured Latency (15% Contrast) at Week 4	119.25; 131.7	—
PRIMARY VEP-Measured Amplitude (85% Contrast) at Week 4	8.4108333; 9.8224	—
PRIMARY VEP-Measured Latency (85% Contrast) at Week 4	119.4166667; 122.3	—
PRIMARY Pelli-Robson Contrast Sensitivity Chart Score at Baseline	1.4; 1.26	—
PRIMARY Pelli-Robson Contrast Sensitivity Chart Score at Week 4	1.39; 1.08	—
PRIMARY Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Baseline	0.08; 0.16	—
PRIMARY Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Week 4	0.10; 0.16	—

Eligibility Criteria

Inclusion Criteria

Live in a community, residential setting (i.e., non-institutionalized, not homeless)
Diagnosis of glaucoma (not type-specific, excluding traumatic glaucoma): Moderate defect or worse in both eyes but not total blindness
Visual field defects present for at least 6 months
Best-corrected visual acuity of 20/200 (1.0 logMAR) or better in at least one eye
Commitment to comply with study procedures (2 week period of intervention sessions) with baseline, post-intervention, and follow-up visits

Exclusion Criteria

Other optic comorbidity than glaucoma
End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
Other diseases of the retina or cataracts responsible for worse than 20/70 best-corrected visual acuity
Photosensitivity to flickering lights
Intraocular Pressure (IOP) > 27 mmHg at baseline
Medically diagnosed memory disorder or Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27
Electric or electronic implants (e.g., cardiac pacemaker)
Metallic artifacts/implants in head and/or torso
Diagnosed epilepsy
Epileptic seizure within the past 3 years of enrollment date
Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
Metastatic disease
Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would preclude reliable testing and participation
Unstable medical conditions (e.g., diabetes, diabetes causing diabetic retinopathy)
Claustrophobia (to limit functional neuroimaging)
Received rtACS in the past

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03188042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.