Status:
COMPLETED
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
Lead Sponsor:
Nu Eyne Co., Ltd.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
19-60 years
Phase:
NA
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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).)
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05271422
Start Date
February 28 2020
End Date
December 14 2020
Last Update
March 9 2022
Active Locations (1)
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1
Department of Ophthalmology, Samsung Medical Center
Seoul, South Korea, 06351