Electrical stimulation treatment for open-angle glaucoma

Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma

This study tests if a new home device that uses electrical stimulation can help adults with open-angle glaucoma protect their vision and eye health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 4 sites (Palo Alto, California and 3 other locations)
• Trial ID: NCT05626491 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of long-term electrical stimulation using a home-stimulation device for patients with open-angle glaucoma. Participants will receive either repetitive transorbital alternating current stimulation (rtACS) or a sham treatment to assess the impact on their visual field and overall eye health. The study will include adults who meet specific visual field criteria and have clinically stable eye pressure. The goal is to determine if this innovative approach can slow the progression of glaucoma.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of open-angle glaucoma and specific visual field measurements.

Not a fit: Patients with stable eye pressure but not meeting the visual field criteria or those with other types of glaucoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, non-invasive option for managing open-angle glaucoma and preserving vision.

How similar studies have performed: While this approach is innovative, similar studies using electrical stimulation for eye conditions have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Participant must be at least 18.
2. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
3. 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 positives do not exceed 20%.
4. Visual Field Index between 10 and 90%
5. Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)
6. In the opinion of the investigator the participant's eye pressure must be clinically stable.
7. If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
8. 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:

1. Participant is unable to comply with study procedures or follow-up visits.
2. Participant has a history of ocular herpes zoster.
3. Participant has pathological nystagmus
4. Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
5. Participant has evidence of corneal opacification or lack of optical clarity.
6. Participant has uveitis or other ocular inflammatory disease.
7. Participant has any electric or electronic implants such as a pacemaker.
8. Participant has acute conjunctivitis.
9. Participant has acute autoimmune disease.
10. 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.
11. Participant is pregnant or lactating.
12. 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. Including but not limited to all forms of dementia.
13. Unresected brain tumors
14. Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable
15. Patients with any skin damage.
16. Children and comatose patients.
17. Patients with history of epileptic seizure within the last 10 years.
18. Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
19. Self-reported alcohol or illicit drug addictions within the last 12 months.
20. Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation
21. Prior participation in a vision training/stimulation study in the last 12 months

Where this trial is running

Palo Alto, California and 3 other locations

• Byers Eye Institute — Palo Alto, California, United States (RECRUITING)
• NYU- Langone — New York, New York, United States (RECRUITING)
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
• Otto-von-Guericke University — Magdeburg, Germany (RECRUITING)

Study contacts

• Principal investigator: Jeffrey L Goldberg, MD PhD — Stanford University

Conditions: Glaucoma, Glaucoma, Open-Angle