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

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.

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).)