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

NCT05159414 | Completed

• 1 other identifier: NE_RTN_001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Changes in parapapillary retinal nerve fiber layer thickness (RNFLT) using optical coherence tomography(OCT)

  baseline, 6, 16 weeks

• Changes in Laminar cribrosa (LC) depth 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 macular vessel density (mVD) using Optical coherence tomography angiography(OCT-A)

  baseline, 6, 16 weeks

Study Arms (1)

Glaucoma patients

EXPERIMENTAL

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

Interventions

Pulse Electrical Stimulation DEVICE

Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

Glaucoma patients

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• All other female patients will be considered WOCBP.
• A person who voluntarily agreed to participate in this clinical trial

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (1)

Department of Ophthalmology, Konkuk University Medical Center

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Youn Hye Jo, Ph. D

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 16, 2021
• Study Start: May 4, 2021
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)