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Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration

NCT07700147 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-13

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • Nu Eyne Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dohyoung Kim · Nu Eyne Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2027-12-09
Completion
2028-04-17

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700147 on ClinicalTrials.gov