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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Dry eye disease patients (n=12) |
|
| Control Group | Sham Comparator | Dry eye disease patients (n=12) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Pulse Electrical Stimulation (NuEyne 01) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Ocular Surface Disease Index (OSDI) score | Check the changes in Ocular Surface Disease Index (OSDI) score | baseline, 1, 4, 12 weeks |
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | Time Frame: baseline, 1, 4, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) | Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) | baseline, 1, 4, 12 weeks |
| Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet any of the exclusion criteria are excluded from this clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Donghui Lim, Ph. D., MD. | Department of Ophthalmology, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Samsung Medical Center | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Sham Pulse Electrical Stimulation | Device | 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. |
|
Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
| baseline, 1, 4, 12 weeks |
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 1 day, 3 days, 7 days |
| Changes in Staining Score | Check the changes in Staining Score | baseline, 1, 4, 12 weeks |
| Changes in Matrix Metalloproteinase-9 (MMP-9) level | Check the changes in Matrix Metalloproteinase-9 (MMP-9) level | baseline, 4, 12 weeks |
| Changes in LipiView Eye Lipid Layer Thickness | Check the changes in LipiView Eye Lipid Layer Thickness | baseline, 4, 12 weeks |
| Changes in Tear Volume | Check the changes in Tear Volume | baseline, 1, 4, 12 weeks |
| Changes in Tear Osmolarity | Check the changes in Tear Osmolarity | 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 | baseline, 1, 4, 12 weeks |