Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma Patients

This is an interventional treatment trial for Glaucoma Read More

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.)