An Open-Label Study to Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies

Stanford University1 site in 1 country40 target enrollmentFebruary 27, 2023

ConditionsGlaucoma Glaucoma, Open-Angle Optic Nerve Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Stanford University
Enrollment: 40
Locations: 1
Primary Endpoint: Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.

Detailed Description

This is a concurrent open-label study for patients who are deemed safe to participate in the electrical stimulation trial but do not fit the exact criteria for the randomized clinical trial.

Registry

clinicaltrials.gov

Start Date

February 27, 2023

End Date

December 1, 2027

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Jeffrey L Goldberg

Professor of Ophthalmology

Stanford University

Eligibility Criteria

Inclusion Criteria

•Participant must be at least
•Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
•Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false postivies do not exeed 20%.
•In the opinion of the investigator the participant's eye pressure must be clinically stable.
•If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
•Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Exclusion Criteria

•Participant is unable to comply with study procedures or follow-up visits.
•Participant has a history of ocular herpes zoster.
•Participant has pathological nystagmus
•Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
•Participant has evidence of corneal opacification or lack of optical clarity.
•Participant has uveitis or other ocular inflammatory disease.
•Participant has any electric or electroinc implants such as a pacemaker.
•Participant has acute conjunctivitis.
•Participant has acute autoimmune disease.
•Participant is pregnant or lactating.

Outcomes

Primary Outcomes

Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).

Time Frame: Baseline through 6 months

Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).

Time Frame: Baseline through 6 months

Secondary Outcomes

Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).(Baseline through 6 months)
Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared).(Baseline through 6 months)
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.(Baseline through Month 6)
Change from baseline in visual evoked potential.(Baseline through Month 6)
Change from baseline in retinal metabolic analysis(RMA)/OcuMet imaging.(Baseline through Month 6)
Change from baseline in adaptive optics retinal imaging.(Baseline through Month 6)
Change from baseline in laser speckle flowgraphy(Baseline through Month 6)
Change from baseline in OCT angiography(Baseline through Month 6)