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Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery

NCT06120348 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2023-11-13

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of applying pulse Electrical Stimulation around eye after laser keratoplasty (LASEK) in patients with dry eye syndrome.

Conditions

Interventions

DEVICE

Charge-Balanced, Symmetric Nerve Stimulation

Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

DEVICE

Sham Stimulation

Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

Sponsors & Collaborators

  • Nu Eyne Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong Hui Lim, Ph. D., MD · Department of Ophthalmology, Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-04-30
Completion
2024-08-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT06120348 on ClinicalTrials.gov