Glaucoma
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eyes of glaucoma patients.
Detailed 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).
Interventions
DEVICEPulse Electrical Stimulation
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Sponsors
Nu Eyne Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in intraocular pressure | baseline, 2, 6, 12, 16 weeks | Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks |
| Changes in visual acuity | baseline, 2, 6, 12, 16 weeks | Check the change of visual acuity in the baseline, 2, 6, 12, 16 weeks |
| Changes in mean deviation (MD) | baseline, 2, 6, 12, 16 weeks | Check the change of mean deviation(MD) in the baseline, 2, 6, 12, 16 weeks |
| Changes in pattern standard deviation(PSD) | baseline, 2, 6, 12, 16 weeks | Check the change of pattern standard deviation(PSD) in the baseline, 2, 6, 12, 16 weeks |
| Changes in visual field index(VFI) | baseline, 2, 6, 12, 16 weeks | Check the change of visual field index(VFI) in the baseline, 2, 6, 12, 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in N95 amplitude using pattern Electroretinogram(ERG) | baseline, 6, 16 weeks | Check the change of N95 amplitude in the baseline, 6, 16 weeks |
| Changes in circumpapillary vessel density (cpVD) using Optical coherence tomography angiography(OCT-A) | baseline, 6, 16 weeks | Check the change of circumpapillary vessel density(cpVD) in the baseline, 6, 16 weeks |
| Changes in Glaucoma Quality of Life-15 (GQL-15) | baseline, 6, 16 weeks | Check the change of Glaucoma Quality of Life-15(GQL-15) score in the baseline, 6, 16 weeks |
| Changes in N95 latency using pattern Electroretinogram(ERG) | baseline, 6, 16 weeks | Check the change of latency in the baseline, 6, 16 weeks |
| Changes in parapapillary retinal nerve fiber layer thickness (RNFLT) using optical coherence tomography(OCT) | baseline, 6, 16 weeks | Check the change of parapapillary retinal nerve fiber layer thickness(RNFLT) in the baseline, 6, 16 weeks |
| Changes in Laminar cribrosa (LC) depth using optical coherence tomography(OCT) | baseline, 6, 16 weeks | Check the change of Laminar cribrosa(LC) depth in the baseline, 6, 16 weeks |
| Changes in macular ganglion cell-inner plexiform layer thickness (GCIPLT) using optical coherence tomography(OCT) | baseline, 6, 16 weeks | Check the change of macular ganglion cell-inner plexiform layer thickness(GCIPLT) in the baseline, 6, 16 weeks |
| Changes in macular vessel density (mVD) using Optical coherence tomography angiography(OCT-A) | baseline, 6, 16 weeks | Check the change of macular vessel density(mVD) in the baseline, 6, 16 weeks |
Countries
South Korea
Outcome results
None listed