Electrical Stimulation for the Treatment of Glaucoma

Launched by STANFORD UNIVERSITY · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether a home device that uses electrical stimulation can safely help treat open-angle glaucoma, a condition where the nerves in the back of the eye can deteriorate more quickly than normal, regardless of eye pressure. The study aims to see if this long-term treatment can make a difference for patients.

To participate, individuals must be at least 18 years old and have a clinical diagnosis of glaucoma that meets specific criteria, such as having certain results on vision tests. Participants should also have stable eye pressure and be able to follow the study’s requirements. Those who are pregnant, have certain eye conditions, or have specific medical implants may not be eligible. If you join the study, you can expect to use the stimulation device at home and attend follow-up visits to monitor your progress. This trial is currently recruiting participants, and it offers a potential new approach to managing glaucoma.

Gender

ALL

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