Electrical Stimulation for the Treatment of Optic Neuropathies

Launched by STANFORD UNIVERSITY · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat open-angle glaucoma, a condition that damages the nerves at the back of the eye, often without any noticeable symptoms. The researchers want to find out if using a special device that delivers electrical stimulation at home can help improve vision and is safe for patients. They are currently recruiting participants aged 18 and older who have been diagnosed with glaucoma and meet certain vision test criteria.

If you or someone you know has open-angle glaucoma and is interested in participating, it’s important to know that participants will need to follow a schedule for check-ups and tests during the study. To be eligible, individuals should have stable eye pressure and specific test results that suggest their condition is consistent with glaucoma. However, there are several health conditions and circumstances that would prevent someone from joining, such as having certain eye diseases or medical implants. Overall, this trial could provide valuable information about a potential new treatment for glaucoma.

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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 postivies do not exeed 20%.
• • 4. In the opinion of the investigator the participant's eye pressure must be clinically stable.
• • 5. 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.
• • 6. 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 electroinc implants such as a pacemaker.
• • 8. Participant has acute conjunctivitis.
• • 9. Participant has acute autoimmune disease.
• • 10. Participant is pregnant or lactating.
• • 11. 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.
• • 12. Unresected brain tumors
• • 13. 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
• • 14. Patients with any skin damage.
• • 15. Children and comatose patients.
• • 16. Patients with history of epileptic seizure within the last 10 years.
• • 17. Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
• • 18. 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
• • 19. Prior participation in a vision training/stimulation study in the last 12 months