Repetitive Transcranial Alternating Current Stimulation(rtACS) for the Treatment of Optic Neuropathies
The goal of this study is to see whether repeated transcranial alternating current stimulation can activate impaired retinal ganglion cells and improve both structural and functional outcomes in patients with glaucoma.
• 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.