This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular 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
25
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGNune Eye Hospital
Seoul, South Korea
NOT_YET_RECRUITINGNumber of Safety Events
Check the safety issues(AE, SAE, etc.).
Time frame: baseline ~ 16 weeks
Changes in contrast sensitivity
Check the change of contrast sensitivity in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Changes in score of VFQ-25(National Eye Institute)
Check the change of Changes in score of VFQ-25(National Eye Institute) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
Check the change of best corrected visual acuity in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Changes in drusen area using optical coherence tomography(OCT)
Check the change of drusen area using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Changes in drusen volume using optical coherence tomography(OCT)
Check the change of drusen volume using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF)
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks