Clinical trial NCT05159414: Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.)

Primary outcomes:
measure: Changes in intraocular pressure
timeFrame: baseline, 2, 6, 12, 16 weeks
measure: Changes in visual acuity
timeFrame: baseline, 2, 6, 12, 16 weeks
measure: Changes in mean deviation (MD)
timeFrame: baseline, 2, 6, 12, 16 weeks
measure: Changes in pattern standard deviation(PSD)
timeFrame: baseline, 2, 6, 12, 16 weeks
measure: Changes in visual field index(VFI)
timeFrame: baseline, 2, 6, 12, 16 weeks
Secondary outcomes:
measure: Changes in parapapillary retinal nerve fiber layer thickness (RNFLT) using optical coherence tomography(OCT)
timeFrame: baseline, 6, 16 weeks
measure: Changes in Laminar cribrosa (LC) depth using optical coherence tomography(OCT)
timeFrame: baseline, 6, 16 weeks
measure: Changes in macular ganglion cell-inner plexiform layer thickness (GCIPLT) using optical coherence tomography(OCT)
timeFrame: baseline, 6, 16 weeks
measure: Changes in circumpapillary vessel density (cpVD) using Optical coherence tomography angiography(OCT-A)
timeFrame: baseline, 6, 16 weeks
measure: Changes in macular vessel density (mVD) using Optical coherence tomography angiography(OCT-A)
timeFrame: baseline, 6, 16 weeks
measure: Changes in N95 amplitude using pattern Electroretinogram(ERG)
timeFrame: baseline, 6, 16 weeks
measure: Changes in N95 latency using pattern Electroretinogram(ERG)
timeFrame: baseline, 6, 16 weeks
measure: Changes in Glaucoma Quality of Life-15 (GQL-15)
timeFrame: baseline, 6, 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Youn Hye Jo, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: