Electrical Stimulation for Vision Neuroenhancement in Glaucoma

Launched by STANFORD UNIVERSITY · Nov 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with glaucoma, specifically a type called normal tension glaucoma. The study will test a device called EYETRONIC, which uses a method called transorbital alternating current stimulation (rtACS) to see if it can help improve vision. The trial is in the early stages and is not yet recruiting participants, but it aims to include adults aged 18 and older who can follow the study requirements. To be eligible, participants must have specific vision test results and stable eye pressure.

If you join this study, you will go through some assessments to ensure you meet the criteria. It's important to note that some people may not be able to participate if they have certain eye conditions or health issues, like a history of eye infections or if they are pregnant. Participants will need to understand the study and provide consent, meaning they agree to take part after being informed about what the study involves. Overall, this trial is an opportunity to explore a new way to support vision health in glaucoma patients.

Gender

ALL

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.