RECRUITING

Electrical Stimulation for Vision Neuroenhancement in Glaucoma

Conditions

Glaucoma Glaucoma Open-Angle open-angle glaucoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06685211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Study Team

CONTACT

650-497-5942

glaucomatrials@stanford.edu

Principal Investigator

Jeffrey L Goldberg, MD PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303

United States

Collaborators and Investigators

Sponsor: Stanford University

Jeffrey L Goldberg, MD PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

glaucoma
open-angle glaucoma

Additional Relevant MeSH Terms

Glaucoma
Glaucoma Open-Angle