Health TrialsbyHealthPanel

Electrical Stimulation for Vision Neuroenhancement in Glaucoma

ConditionsGlaucomaGlaucoma Open-Angle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.

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 primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing

Participant's eye pressure must be clinically stable, with IOP < 18.

Disqualifiers

Participant is unable to comply with study procedures or follow-up visits.

Participant has a history of ocular herpes zoster.

Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.

Participant has evidence of corneal opacification or lack of optical clarity.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Eyetronic rtACS

    Device

    The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.

  • Sham rtACS

    Device

    Participants will wear the Eyetronic system but there will be no active stimulations applied.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: rtACS treatmentExperimental treatment 1 intervention
Group B: ShamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Field Index (VFI)

Measuring the change in the Visual Field Index (VFI) from baseline to month 3.

Time frame
3 Months
2

Mean Deviation (MD)

Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.

Time frame
3 Months
3

Pointwise Linear Regression (PLR)

Measuring the PLR of the visual field points from baseline to Month 3.

Time frame
3 Months

Secondary outcomes

1

Ganglion Cell Layer

The change in ganglion cell layer as measured by optical coherence tomography (OCT) through 3 months

Time frame
3 Months
2

Retinal Nerve Fiber Layer

The change in nerve fiber layer thickness as measured by OCT through 3 months

Time frame
3 Months
3

Best Corrected Visual Acuity

The change in best corrected visual acuity (BCVA) through 3 months

Time frame
3 Months
4

Stead-State Visually Evoked Potential

The change in visual evoked potential (VEP) through 3 months

Time frame
3 Months

Other outcomes

Sponsors and contacts

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

Stanford University

Lead sponsor

EYETRONIC, Inc

Collaborator

Source ClinicalTrials.gov
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