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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.
Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.
Department of Ophthalmology, Samsung Medical Center
Seoul, South Korea
Changes in Ocular Surface Disease Index (OSDI) score
Check the changes in Ocular Surface Disease Index (OSDI) score
Time frame: baseline, 1, 4, 12 weeks
Changes in Tear break-up time (T-BUT)
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Time frame: Time Frame: baseline, 1, 4, 12 weeks
Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
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Time frame: baseline, 1, 4, 12 weeks
Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Time frame: baseline, 1, 4, 12 weeks
Changes in Visual Analogue Scale (VAS) score
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Time frame: baseline, 1 day, 3 days, 7 days
Changes in Staining Score
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Time frame: baseline, 1, 4, 12 weeks
Changes in Matrix Metalloproteinase-9 (MMP-9) level
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Time frame: baseline, 4, 12 weeks
Changes in LipiView Eye Lipid Layer Thickness
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Time frame: baseline, 4, 12 weeks
Changes in Tear Volume
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Time frame: baseline, 1, 4, 12 weeks
Changes in Tear Osmolarity
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Time frame: baseline, 4, 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, 12 weeks