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GlaucomaNCT05159414

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

A study testing Pulse Electrical Stimulation in people with Glaucoma, run by Nu Eyne Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Glaucoma
What is being tested?
Pulse Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSouth Korea
Study dates
4 May 2021to 12 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Ophthalmology, Konkuk University Medical Center

    Seoul, 05030

Other trials in South Korea

About this study

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

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

Read the 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
Being tested
Pulse Electrical Stimulation
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulse Electrical StimulationDevice

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

Study groups in NCT05159414
Study groupRoleWhat they receive
Glaucoma patientsExperimentalDuration 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).
Receives: Device: Pulse Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in intraocular pressure

    Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks

    Measured: baseline, 2, 6, 12, 16 weeks

  2. Changes in visual acuity

    Check the change of visual acuity in the baseline, 2, 6, 12, 16 weeks

    Measured: baseline, 2, 6, 12, 16 weeks

  3. Changes in mean deviation (MD)

    Check the change of mean deviation(MD) in the baseline, 2, 6, 12, 16 weeks

    Measured: baseline, 2, 6, 12, 16 weeks

  4. Changes in pattern standard deviation(PSD)

    Check the change of pattern standard deviation(PSD) in the baseline, 2, 6, 12, 16 weeks

    Measured: baseline, 2, 6, 12, 16 weeks

  5. Changes in visual field index(VFI)

    Check the change of visual field index(VFI) in the baseline, 2, 6, 12, 16 weeks

    Measured: baseline, 2, 6, 12, 16 weeks

Secondary outcomes (8)

  1. 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

    Measured: baseline, 6, 16 weeks

  2. 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

    Measured: baseline, 6, 16 weeks

  3. 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

    Measured: baseline, 6, 16 weeks

  4. 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

    Measured: baseline, 6, 16 weeks

  5. 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

    Measured: baseline, 6, 16 weeks

  6. Changes in N95 amplitude using pattern Electroretinogram(ERG)

    Check the change of N95 amplitude in the baseline, 6, 16 weeks

    Measured: baseline, 6, 16 weeks

  7. Changes in N95 latency using pattern Electroretinogram(ERG)

    Check the change of latency in the baseline, 6, 16 weeks

    Measured: baseline, 6, 16 weeks

  8. 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

    Measured: baseline, 6, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start4 May 2021
  3. Primary completion12 Jan 2023
  4. Study completion12 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159414
Sponsor's protocol ID
NE_RTN_001
Status last verified
Sep 2023
First submitted
2 Nov 2021
Last updated
11 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulse Electrical Stimulation in people with Glaucoma, run by Nu Eyne Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in intraocular pressure (time frame: baseline, 2, 6, 12, 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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