Phase
Condition
Glaucoma
Treatment
DC-Stimulator MC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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%. Thevisual 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 MDbetween two consecutive visual field tests must be less than 2 dB.
Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulationtreatment.
If a participant has two eyes meeting study criteria, one eye will be randomlyselected by computer for study participation.
In the opinion of the investigator the participant's eye pressure must be clinicallystable.
Participant must has the ability to comply with the requirements of the study andcomplete the schedule of events.
Participant must understand and sign the informed consent. If the participant'svision is impaired to the point where he/she cannot read the informed consentdocument, the document will be read to the participant in its entirety.
Optical coherence tomography (OCT) imaging shows measurable changes in eitherperipapillary retinal nerve fiber layer (RNFL) thickness or macular ganglioncell-inner plexiform layer thickness.
Exclusion
Exclusion Criteria:
History of ocular herpes.
Pathological nystagmus.
Retinal disease sufficient to affect vision.
Corneal opacity affecting vision.
Cataract affecting vision.
Uveitis or other intraocular inflammatory disease.
Implanted electronic devices such as a pacemaker.
Rheumatologic or autoimmune disease.
Brain tumor or intracranial magnetic metallic implants.
History of epilepsy.
Periocular skin lesions.
Anxiety with Geriatric Anxiety Scale score > 12.
History of claustrophobia.
Participation in another clinical trial within the past 3 months involvingmedication or training that could affect the eyes.
Physical or mental conditions that may increase the risk of participation orinterfere with study assessments (e.g., dementia).
Previous ocular electrical stimulation treatment or visual training study within thepast 12 months.
Uncontrolled hypertension or diabetes.
Pregnant or breastfeeding.
History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascularmalformation, or intracranial surgery.
Study Design
Connect with a study center
National Taiwan University Hospital
Taipei 1668341, Hawaii 100
TaiwanActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.