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

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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Pulse Electrical Stimulation

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).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Department of Ophthalmology, Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glaucoma patients; 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).	Device: Pulse Electrical Stimulation; Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in intraocular pressure	Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks	baseline, 2, 6, 12, 16 weeks
Changes in visual acuity	Check the change of visual acuity in the baseline, 2, 6, 12, 16 weeks	baseline, 2, 6, 12, 16 weeks
Changes in mean deviation (MD)	Check the change of mean deviation(MD) in the baseline, 2, 6, 12, 16 weeks	baseline, 2, 6, 12, 16 weeks
Changes in pattern standard deviation(PSD)	Check the change of pattern standard deviation(PSD) in the baseline, 2, 6, 12, 16 weeks	baseline, 2, 6, 12, 16 weeks
Changes in visual field index(VFI)	Check the change of visual field index(VFI) in the baseline, 2, 6, 12, 16 weeks	baseline, 2, 6, 12, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parapapillary retinal nerve fiber layer thickness (RNFLT) using optical coherence tomography(OCT)	Check the change of parapapillary retinal nerve fiber layer thickness(RNFLT) in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in Laminar cribrosa (LC) depth using optical coherence tomography(OCT)	Check the change of Laminar cribrosa(LC) depth in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in macular ganglion cell-inner plexiform layer thickness (GCIPLT) using optical coherence tomography(OCT)	Check the change of macular ganglion cell-inner plexiform layer thickness(GCIPLT) in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in circumpapillary vessel density (cpVD) using Optical coherence tomography angiography(OCT-A)	Check the change of circumpapillary vessel density(cpVD) in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in macular vessel density (mVD) using Optical coherence tomography angiography(OCT-A)	Check the change of macular vessel density(mVD) in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in N95 amplitude using pattern Electroretinogram(ERG)	Check the change of N95 amplitude in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in Glaucoma Quality of Life-15 (GQL-15)	Check the change of Glaucoma Quality of Life-15(GQL-15) score in the baseline, 6, 16 weeks	baseline, 6, 16 weeks
Changes in N95 latency using pattern Electroretinogram(ERG)	Check the change of latency in the baseline, 6, 16 weeks	baseline, 6, 16 weeks

Collaborators and Investigators

• Sponsor: Nu Eyne Co., Ltd.
• Investigators: Principal Investigator: Youn Hye Jo, Ph. D, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: NE_RTN_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No