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