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The pilot study of Eye and surround the eye nerve stimulation after LASEK(Laser Asisted Sub-Epithelial Keratomileusis) with dry eye.

Not Applicable
Recruiting
Conditions
Diseases of the eye and adnexa
Registration Number
KCT0004602
Lead Sponsor
u Eyne
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
24
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

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)

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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