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

Nu Eyne

Status

Completed

Conditions

Glaucoma

Treatments

Device: Pulse Electrical Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05159414

NE_RTN_001

Details and patient eligibility

About

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

Full description

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).

Enrollment

18 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.)