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This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eyes of 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Electrical Stimulation | Device | Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks. |
|
| 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 |
| 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) |
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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:
All other female patients will be considered WOCBP.
A person who voluntarily agreed to participate in this clinical trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youn Hye Jo, Ph. D | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Konkuk University Medical Center | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 N95 latency using pattern Electroretinogram(ERG) | Check the change of latency 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 |