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Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery

NCT05271422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-03-09

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eye in dry eye disease patients who are scheduled for LASEK surgery.

Conditions

Interventions

DEVICE

Real Pulse Electrical Stimulation (NuEyne 01)

Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.

DEVICE

Sham Pulse Electrical Stimulation

Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.

Sponsors & Collaborators

  • Nu Eyne Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2020-12-14
Completion
2020-12-14

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 NCT05271422 on ClinicalTrials.gov