Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery
NCT ID: NCT06120348
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
178 participants
INTERVENTIONAL
2023-08-31
2024-08-31
Brief Summary
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Detailed Description
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Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group
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.
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.
Control Group
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
Sham Stimulation
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
Interventions
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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.
Sham Stimulation
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Those who are scheduled to get LASEK surgery
* Those who have had dry eye symptoms for more than 3 months.
* According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
* Those who TBUT test results of less than 10 seconds
* Those who OSDI score of 13 or higher
* Those who agreed to use contraception using a medically acceptable method during the period of clinical trial among Women of child bearing potential (WOCBP).
* A person who voluntarily agreed to participate in this clinical trial.
Exclusion Criteria
* A person with an uncontrollable systemic chronic disease.
* 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, Punctal plug insertion, Pterygium surgery)
* 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
* A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
* 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).)
* Those who wore contact lenses within 72 hours before screening or who must wear contact lenses during the clinical trial period
* Those who have taken the relevant systemic drugs (steroids, immunosuppressants, omega-3 and anticholinergic drugs, etc.) within 30 days from the date of screening
* Those who are judged to have problems attaching electrodes due to inflammatory reactions or other dermatological problems in the skin around the orbit where the electrodes of medical devices are attached
* Those who participated in other clinical trial within 30 days from the screening date
19 Years
60 Years
ALL
No
Sponsors
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Nu Eyne Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dong Hui Lim, Ph. D., MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Samsung Medical Center
Locations
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HanGil Medical Foundation
Incheon, , South Korea
Department of Ophthalmology, Kangbuk Samsung Hospital
Seoul, , South Korea
Department of Ophthalmology, Severance Hospital
Seoul, , South Korea
Nune Eye Hospital
Seoul, , South Korea
Department of Ophthalmology, Samsung Medical Center
Seoul, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang Mok Lee, Ph. D., MD
Role: primary
Chul Young Choi, Ph. D., MD
Role: primary
Tae-im KIM, Ph. D., MD
Role: primary
Kyoung Yoon Shin, Ph. D., MD
Role: primary
Kyung min Koh, Ph. D., MD
Role: primary
Other Identifiers
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NE_DED_003
Identifier Type: -
Identifier Source: org_study_id
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