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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Department of Ophthalmology, Konkuk University Medical Center
Seoul, South Korea
Changes in intraocular pressure
Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 2, 6, 12, 16 weeks
Changes in visual acuity
Check the change of visual acuity in the baseline, 2, 6, 12, 16 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 2, 6, 12, 16 weeks
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
Time frame: 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
Time frame: baseline, 6, 16 weeks
Changes in macular ganglion cell-inner plexiform layer thickness (GCIPLT) using optical coherence tomography(OCT)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Check the change of macular ganglion cell-inner plexiform layer thickness(GCIPLT) in the baseline, 6, 16 weeks
Time frame: 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
Time frame: 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
Time frame: baseline, 6, 16 weeks
Changes in N95 amplitude using pattern Electroretinogram(ERG)
Check the change of N95 amplitude in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Changes in N95 latency using pattern Electroretinogram(ERG)
Check the change of latency in the baseline, 6, 16 weeks
Time frame: 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
Time frame: baseline, 6, 16 weeks