A Comparative Study on the Efficacy and Safety of Biodegradable Microneedle Acupunture and Conventional Intradermal Acupuncture for Dry Eye
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0007358
- Lead Sponsor
- aju Dongshin University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Participants should satisfy all following criteria;
1. Male and female patients aged 19-65 at the screening visit.
2. Patients who have typical dry eye symptoms including pruritus, foreign body sensation, pain, dryness, blurry eye, dazzle, eye congestion, and illacrimation, and whose Ocular Surface Disease Index score is more than 13.
3. Less than 10 mm/5 min in Schirmer ? test.
4. Patients who submitted written consent voluntarily.
Patients who satisfy any criterion of the followings cannot participate in this study;
1. Dry eye syndrome caused by eyelid or eyelashes.
2. Irritated eye caused by acute inflammation arose from eyelid, eyeball, or ocualr appendage.
3. Diagnosed as skin diseases including Stevens-Johnson syndrome, pemphigoid, or etc.
4. Diagnosed as vitamin A deficiency.
5. Patients who have damages caused by injury of eyeball or ocular appendage.
6. Patients who had operation to anterior segment of the eye or operation via anterior eye including cataract or LASIK within recent 3 months.
7. Have a difficulty in blink because of facial palsy.
8. Received punctal plug or punctal occlusion.
9. Used anti-inflammatory drops including cyclosporine, corticosteroids, or autoserotherapy directly to the eye within recent 2 weeks.
10. Patients who have active ocular infections including anterior uveitis or anterior blepharitis.
11. Patients who have ocular allergy or who are receiving treatments for allergic eye diseases.
12. Patients who have viral conjunctivitis symptoms or who are receiving treatments for viral conjunctivitis.
13. Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes, or who are diagnosed as glaucoma.
14. Receiving systemic corticosteroids or immunosuppressants treatment.
15. Pregnant, lactating women, or women planning pregnancy.
16. Other cases which investigators determined inadequate.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular Surface Disease Index(OSDI)
- Secondary Outcome Measures
Name Time Method Visual analogue scale for subjective symptoms;Quality of Life;Schirmer ? test;General assessment