A Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Electroacupuncture and Its Cotreatment with Electronic Moxibustion for Dry eye syndrome
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0009622
- Lead Sponsor
- aju Dongshin University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 45
Participants should meet all of the following criteria:
(1) Male or female patients aged 19-70 at the screening visit.
(2) Patients with ocular surface disease index (OSDI) score of =13.
(3) Patients with tear film break-up time (TFBUT) of = 10 seconds.
(4) Patients who can read and write Korean and voluntarily submitted written consent with their signature.
Participants who have any of the following criteria are not eligible to participate in this study:
(1) Patients with dry eye syndrome caused by eyelids or eyelashes.
(2) Patients with Irritated eye caused by acute inflammation arising from the eyelid, eyeball, or ocular appendage.
(3) Patients who wore contact lenses within the recent 2 weeks or who have to wear contact lenses during the trial period.
(4) Patients who had an operation to the anterior segment of the eye or operation via the anterior eye including cataract or LASIK within recent 3 months.
(5) Patients who used anti-inflammatory drops, including cyclosporine, corticosteroids, or autoserotherapy, directly to the eye, within recent 2 weeks.
(6) Patients who are diagnosed with vitamin A deficiency.
(7) Patients who have difficulty in blink due to facial palsy.
(8) Patients who received punctal plug or punctal occlusion.
(9) Patients who have damages caused by injury of the eyeball or ocular appendage.
(10) Patients who have secondary dry eye syndrome due to scarring caused by irradiation, alkali burn, Stevens-Johnson syndrome, or cicatrical pemphigoid.
(11) Patients who are receiving treatments for allergic ocular conditions or viral conjunctivitis.
(12) Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes or who are diagnosed with glaucoma.
(13) Patients who have active ocular infections including anterior uveitis or anterior blepharitis.
(14) Patients taking systemic corticosteroids or immunosuppressants.
(15) Patients who have an implant in the body that is unsuitable for acupuncture treatment, including pacemaker and implantable defibrillator, or are sensitive to electroacupuncture treatment.
(16) Pregnant, lactating women, or women planning pregnancy.
(17) Others whom investigators determined ineligible.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method