study of application of pulse electrical stimulation around eye in glaucoma patients

Conditions: Glaucoma

Summary: this study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eyes of glaucoma patients.

duration of study period(per participant): screening period(0-4weeks), intervention period(16weeks) patient needs to visit site at least 5 times(screening, v2, v3, v4, v5). v2 can be done with screening visit. visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(baseline).

Eligibility criteria:
inclusion criteria: * participants must be 19 to 75 years of age, at the time of screening * patients with normal tension glaucoma or open angle glaucoma * patients with best-corrected visual acuity of 20/40 or more * patients whose mean deviation(md) value of visual field test is -6db or less * patients who have stable eye pressure of less than 20mmhg over the past 2 months * if glaucoma treatment is in progress, the type, dose, and form of drug for treatment are stable for more than 2 months * a person who has no pregnancy plan during the clinical trial period and has agreed to an effective contraceptive plan for wocbp(women of child bearing potential) * woncbp(women of non-child bearing potential) must meet at least one of the following criteria: 1. postmenopausal women who are at least 45 years old and had no menses for 24 consecutive months 2. a woman who underwent hysterectomy of bilateral ovarian resection recorded by a doctor * all other female patients will be considered wocbp. * a person who voluntarily agreed to participate in this clinical trial exclusion criteria: * ophthalmological and neurological diseases that can affect visual field test(e.g., optic neuritis, diabetic retinopathy, age-related macular degeneration, and the epiretinal membrane) * a person with a history of surgery related to eyeball excluding simple cataract surgery or orbital surgery such as orbital fracture * those who have more than -6d of refractive errors * those who have cataracts of etdrs(early treatment diabetic retinopathy study) grade 3 or higher * those who have a history of trauma around the eyeball, such as an orbital fracture, etc., * patients with active malignancy or history of malignancy, except completely treated in situ carcinoma of the cervix, completely treated and resected non-metastatic squamous of basal cell carcinoma of the skin. * a person who recently(within 1 month before the clinical trial medical device is applied) suffered severe trauma or underwent major surgery * pregnant or lactating women * any other severe acute or chronic medical or psychological conditions * those who can't understand or read the consent form of this clinical trial(e.g. illiterate or foreigners) * any other cases that pi considers hard to participate in this clinical trial(e.g. heart-related problems, seizure, epilepsy. patients transplanted metal or electronic device in head \& neck. patient suffering from unknown pain. patients who are warned not to use out clinical trial device or is prohibited from using it.) * in the case of participating in other clinical trials within 6 months prior to the time of obtaining the consent form * subjects who are not suitable for the clinical trial, are likely to be in danger when participate in the study or interfere with the interpretation of the trial results. * brain and neck implant or pacemaker including deep brain stimulation device. implantable or wearable cardioverter defibrillator. (dental implants are accepted.)