Clinical trial NCT06685211: Electrical Stimulation for Vision Neuroenhancement in Glaucoma
Official title: A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Glaucoma Open-Angle
Keywords: glaucoma
open-angle glaucoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Neuromodtronic, GmbH
First posted: 2024-11-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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 normal tension glaucoma 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.
* If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, 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 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.
* Participant has uveitis or other ocular inflammatory disease.
* Participant is receiving systemic steroids or other immunosuppressive medications.
* Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
* Participant is pregnant or lactating.
* Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
* Patients with opened skull, after trepanation or with heart and brain pacemaker.
* Patients with implanted intracranial metals such as clippings, coilings, ventriculo-peritoneal shunts, endoprosthesis etc.
* Patients with any skin damage in the area of electrode placement.
* Children and comatose patients.
* Patients with recent history of epileptic seizure.
* Patients with uncontrolled high levels of blood pressure (\<160 mmHg) or uncontrolled high levels of intraocular pressure (\<27 mmHg).
* Patients abusing drugs or alcohol.

Primary outcomes:
measure: Visual Field Index (VFI)
timeFrame: 3 Months
measure: Mean Deviation (MD)
timeFrame: 3 Months
measure: Pointwise Linear Regression (PLR)
timeFrame: 3 Months
Secondary outcomes:
measure: Ganglion Cell Layer
timeFrame: 3 Months
measure: Retinal Nerve Fiber Layer
timeFrame: 3 Months
measure: Best Corrected Visual Acuity
timeFrame: 3 Months
measure: Stead-State Visually Evoked Potential
timeFrame: 3 Months
measure: OCT-Angiography
timeFrame: 3 Months
measure: Retinal Metabolic Analysis
timeFrame: 3 Months
measure: Visual Field indicies in Non-Study Eye
timeFrame: 3 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jeffrey L Goldberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: