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

NCT ID: NCT05159414

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2023-01-12

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).

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Pulse Electrical Stimulation

Intervention Type: DEVICE

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

Interventions

Pulse Electrical Stimulation

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

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nu Eyne Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youn Hye Jo, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Department of Ophthalmology, Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

NE_RTN_001

Identifier Type: -

Identifier Source: org_study_id