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

Nu Eyne

Status

Completed

Conditions

Dry Eye Disease

Treatments

Device: Real Pulse Electrical Stimulation (NuEyne 01)

Device: Sham Pulse Electrical Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05271422

NE_DED_001

Details and patient eligibility

About

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.

Full description

Duration of study period (per participant): Screening period (0-14 days), Intervention period (12 weeks), F/U period (2 weeks) Patient needs to visit site at least 9 times (Screening, baseline, V1, V2, V3, Tele-visit, V4, V5, F/U Tele-visit). Baseline visit will be done on the day of surgery. Visit 1, 2, 3, Tele-visit, 4, 5, F/U Tele-visit is 1 day, 3 days, 1 weeks, 2 weeks, 4 weeks, 12 weeks and 16weeks after baseline visit.

Enrollment

24 patients

Sex

All

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must be 19 to 60 years of age, at the time of screening
Those who are scheduled to get LASEK surgery
According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
Those with an OSDI score of 13 or higher
A person who has no pregnancy plan during the clinical trial period and has agreed to an effective contraceptive plan for Women of child bearing potential (WOCBP) by a doctor
A person who voluntarily agreed to participate in this clinical trial

Exclusion criteria

Patients who meet any of the exclusion criteria are excluded from this clinical trial.

A person with an uncontrollable systemic chronic disease (diabetes mellitus)
Those who are allergic to drugs such as Fluorescein Solution or ophthalmic anesthetics
In a case where there is a history of receiving ophthalmic surgery known to affect the tear layer within the last 6 months (e.g., Cataract, Pterygium surgery)
A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
A person who has eyelid diseases or structural abnormalities
A person with acute eye infection or inflammation of the eyeball not related to Meibomian gland dysfunction
A person with abnormalities in the eyelids or eyelashes
A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery (e.g., detachment of the retina, cataract)
Pregnant or lactating women
Those who can't understand or read the consent form of this clinical trial (e.g., illiterate or foreigners)
Any other cases that PI considers hard to participate in this clinical trial (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use our clinical trial device or is prohibited from using it (e.g., pacemaker user).)