NCT05159414
Completed
Not Applicable
A Single Center, Open-label, Exploratory Study to Evaluate the Efficacy and Safety of the Application of Pulse Electrical Stimulation Around the Eye in Glaucoma Patients
ConditionsGlaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Nu Eyne Co., Ltd.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Changes in intraocular pressure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
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:
- •Postmenopausal women who are at least 45 years old and had no menses for 24 consecutive months
- •A woman who underwent hysterectomy of bilateral ovarian resection recorded by a doctor
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)
Outcomes
Primary Outcomes
Changes in intraocular pressure
Time Frame: baseline, 2, 6, 12, 16 weeks
Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks
Changes in pattern standard deviation(PSD)
Time Frame: 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 acuity
Time Frame: 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)
Time Frame: baseline, 2, 6, 12, 16 weeks
Check the change of mean deviation(MD) in the baseline, 2, 6, 12, 16 weeks
Changes in visual field index(VFI)
Time Frame: baseline, 2, 6, 12, 16 weeks
Check the change of visual field index(VFI) in the baseline, 2, 6, 12, 16 weeks
Secondary Outcomes
- Changes in N95 amplitude using pattern Electroretinogram(ERG)(baseline, 6, 16 weeks)
- Changes in Glaucoma Quality of Life-15 (GQL-15)(baseline, 6, 16 weeks)
- Changes in parapapillary retinal nerve fiber layer thickness (RNFLT) using optical coherence tomography(OCT)(baseline, 6, 16 weeks)
- Changes in macular ganglion cell-inner plexiform layer thickness (GCIPLT) using optical coherence tomography(OCT)(baseline, 6, 16 weeks)
- Changes in circumpapillary vessel density (cpVD) using Optical coherence tomography angiography(OCT-A)(baseline, 6, 16 weeks)
- Changes in N95 latency using pattern Electroretinogram(ERG)(baseline, 6, 16 weeks)
- Changes in macular vessel density (mVD) using Optical coherence tomography angiography(OCT-A)(baseline, 6, 16 weeks)
- Changes in Laminar cribrosa (LC) depth using optical coherence tomography(OCT)(baseline, 6, 16 weeks)
Study Sites (1)
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