Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies

Ki vehet részt

• Participant must be at least 18
• Clinical diagnosis of glaucoma, with Humphrey Visual Field 24-2 mean deviation (MD) between -22 dB and -5 dB, and Visual Field Index (VFI) between 10% and 90%. The visual field test at screening must meet the following reliability indices:; Fixation losses (FL) ≤ 33%; False-negative rate (FNR) ≤ 20%; False-positive rate (FPR) ≤ 20% At initial screening, the difference in MD between two consecutive visual field tests must be less than 2 dB
• Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulation treatment
• If a participant has two eyes meeting study criteria, one eye will be randomly selected by computer for study participation
• In the opinion of the investigator the participant's eye pressure must be clinically stable
• Participant must has the ability to comply with the requirements of the study and complete the schedule of events
• 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
• Optical coherence tomography (OCT) imaging shows measurable changes in either peripapillary retinal nerve fiber layer (RNFL) thickness or macular ganglion cell-inner plexiform layer thickness

Ki nem vehet részt

• Brain tumor or intracranial magnetic metallic implants
• Participation in another clinical trial within the past 3 months involving medication or training that could affect the eyes
• Previous ocular electrical stimulation treatment or visual training study within the past 12 months
• History of ocular herpes
• Retinal disease sufficient to affect vision
• Uveitis or other intraocular inflammatory disease
• Rheumatologic or autoimmune disease
• History of epilepsy
• History of claustrophobia
• Physical or mental conditions that may increase the risk of participation or interfere with study assessments (e.g., dementia)
• Uncontrolled hypertension or diabetes
• History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascular malformation, or intracranial surgery
• Pathological nystagmus
• Corneal opacity affecting vision
• Cataract affecting vision
• Implanted electronic devices such as a pacemaker
• Periocular skin lesions
• Anxiety with Geriatric Anxiety Scale score > 12
• Pregnant or breastfeeding