Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07700147
NA

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.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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