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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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 Comparator | Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Charge-Balanced, Symmetric Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | baseline, 12 weeks |
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | baseline, 1, 4, 8 weeks |
| Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinho Jung, Ph.D Candi. | Contact | +821083113509 | jinho.jung@nueyne.com | |
| PyeongHwa Eun, M.S. | Contact | +821095513095 | pyeonghwa.eun@nueyne.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Hui Lim, Ph. D., MD | Department of Ophthalmology, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HanGil Medical Foundation | Recruiting | Incheon | 21388 | South Korea |
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| Sham Stimulation | Device | Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. |
|
Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score
| baseline, 1, 4, 8, 12 weeks |
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 3 days, 4, 8, 12 weeks |
| Changes in Staining Score | Check the changes in Staining Score | 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 | baseline, 1, 4, 8, 12 weeks |
| Changes in Tear Volume | Check the changes in Tear Volume | baseline, 1, 4, 8, 12 weeks |
| Department of Ophthalmology, Kangbuk Samsung Hospital | Recruiting | Seoul | 03181 | South Korea |
|
| Department of Ophthalmology, Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Nune Eye Hospital | Recruiting | Seoul | 06192 | South Korea |
|
| Department of Ophthalmology, Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
|
| Kim's Eye Hospital | Recruiting | Seoul | 07301 | South Korea |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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