Health TrialsbyHealthPanel

Electrical Stimulation for the Treatment of Optic Neuropathies

ConditionsGlaucomaGlaucoma, Open-AngleOptic Nerve Diseases
Trial statusActive, not recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be at least 18.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Repetitive, Transorbital Alternating Current Stimulation (rtACS)

    Device

    Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Active SASmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline through 6 months
2

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

Time frame
Baseline through 6 months

Secondary outcomes

1

Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).

Time frame
Baseline through 6 months
2

Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared).

Time frame
Baseline through 6 months
3

Change from baseline in visual acuity as assessed by the Snellen visual acuity test.

The Snellen test is a standard eye chart test used to test eyesight.

Time frame
Baseline through Month 6
4

Change from baseline in visual evoked potential.

Time frame
Baseline through Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: