Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration
Sponsor: Nu Eyne Co., Ltd.
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration. The main questions this study aims to answer are: * Does the investigational device improve visual function, as assessed by best corrected visual acuity and contrast sensitivity? * What treatment-emergent adverse events occur during the study? Participants will: * Be randomized to receive either active stimulation or sham stimulation * Apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period * Visit the study site for eye examinations and safety assessments * Return for a follow-up visit 4 weeks after the end of treatment
Official title: A Multicenter, Randomized, Double-Blind, Sham-Controlled, Parallel-Group Exploratory Clinical Trial Evaluating the Efficacy and Safety of an Electric Stimulator for Medical Use by Personal (LRTPM1) in Improving Visual Function in Patients With Early to Intermediate Dry Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-07-09
Completion Date
2028-04-17
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Electrical Stimulation
The active intervention uses transcutaneous electrical stimulation (TES) delivered by the investigational personal-use electric stimulator (LRTPM1). Electrodes are attached to the ocular and periocular area, and the device delivers pulsed electrical stimulation. Participants will apply the assigned device once daily for 30 minutes over a 12-week treatment period.
Sham Transcutaneous Electrical Stimulation
The sham device is identical in appearance to the active investigational device but does not provide active electrical stimulation. Participants will apply the assigned sham device once daily for 30 minutes over a 12-week treatment period.
Locations (3)
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Asan Medical Center
Seoul, South Korea