This study aims to evaluate the efficacy and safety of applying pulse Electrical Stimulation around eye after laser keratoplasty (LASEK) in patients with dry eye syndrome.
Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
178
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 device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
HanGil Medical Foundation
Incheon, South Korea
RECRUITINGDepartment of Ophthalmology, Kangbuk Samsung Hospital
Seoul, South Korea
RECRUITINGDepartment of Ophthalmology, Severance Hospital
Seoul, South Korea
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Time frame: baseline, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Time frame: baseline, 1 week
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Time frame: baseline, 1, 4, 8 weeks
Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score
Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Time frame: baseline, 3 days, 4, 8, 12 weeks
Changes in Staining Score
Check the changes in Staining Score
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in the length of the aesthesiometer's filament in centimeters
Check the changes in the length of the aesthesiometer's filament in centimeters
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in Tear Volume
Check the changes in Tear Volume
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nune Eye Hospital
Seoul, South Korea
RECRUITINGDepartment of Ophthalmology, Samsung Medical Center
Seoul, South Korea
RECRUITINGKim's Eye Hospital
Seoul, South Korea
RECRUITINGTime frame: baseline, 1, 4, 8, 12 weeks