None listed
Conditions
Interventions
Medical Device : subject: after LASEK surgery
Experimental group: From post-operation to 2 weeks (1 session 30 minutes per day), From 3week ~ 12week (1 session 30 minutes per week), the intensity cou
Sponsors
Nu Eyne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19(Years old) ~ 60(Years old) both of Male, Female 2. Patients scheduled for LASEK(Laser Epithelial Keratectomy) 3. The person who met with Grade II Korean Corneal Disease study group's Dry eye disease diagnosis guideline 4. OSDI =13 5. Those who do not have a pregnancy plan during the clinical trial period and have agreed to a contraceptive plan for women of childbearing potential. 6. A voluntary written consent to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1. Have an uncontrolled systemic chronic disease (ex. Diabetes) 2. The person who has allergic reaction to medicines such as Fluorescein Solution or eye drops. 3. The person who has a history of ophthalmic surgery that has been known to affect the tear layer within the last 6 months (eg. cataracts, pterygium surgery, etc.) 4. Systemic drug users (tetracycline derivatives, antihistamine, isotretinoin) 5. Eyelid Disease or Structural Abnormalities 6. If there is an acute infection or inflammation of the eye that is not related to Meibomian gland dysfunction 7. What is wrong with the eyelids or eyelashes 8. There is an ocular condition or ophthalmic disease that the operation is deemed inappropriate (eg, retinal detachment, glaucoma, etc.). 9. Pregnant or lactating women 10. The person who cannot understand or cannot read the consent form of this study (ex. Illiterate or foreign) 11.In addition, if the researcher judges that participation is difficult (ex. Heart related problems, seizures, etc., metal or electronic device implanted in the head, unexplained pain, cardiac pacemaker implant, etc.) Including precautions and contraindications)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the score: OSDI(Ocular Surface Disease Index), SPEED-II(Standard Ptient Evaluation for Eye Dryness-II), T-BUT(Tear Break-up Time) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the score: DEQ-5(A Five-item Dry Eye Questionnaire), VAS(Visual Analogue Scale Pain Rating), staining score, MMP-9(Protease test), Lipiview (depth of lipid-layer), Schirmer's test(the tear), Osmol density | — |
Countries
Korea, Republic of
Contacts
Public ContactDonghui Lim
Samsung Medical Center
Outcome results
None listed