Title
Acupuncture for Dry Eye
Acupuncture for Dry Eye: a Multicenter Randomized Controlled Trial With Active Comparison Intervention (Artificial Tear Drop) Using a Mixed Method Approach
Phase
Phase 3Lead Sponsor
Korea Institute of Oriental MedicineStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Dry EyeIntervention/Treatment
cellulose ...Study Participants
150The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.
Dry eye is one of the common diseases in ophthalmology. It affects not only patients' daily activities such as reading, carrying out professional work, using the computer, watching television, and driving, but also bodily health conditions such as bodily pain, discomfort and lower energy and vitality.
Currently, artificial tears are easily subscribed or used in the shape of OTC drugs. However, preservatives in artificial tears may exacerbate ocular surface inflammation and the safety of anti-inflammatory treatment is not well established.
Acupuncture, one of the most popular CAM interventions, showed some favourable effects over artificial tears for dry eye in several randomised controlled trials (RCTs). The evidence obtained from these trials is quite limited because all of these RCTs were conducted under high risk of biases. Therefore, well-designed RCTs are needed to establish the efficacy of acupuncture for dry eye.
In a clinical trial, cost-effectiveness and qualitative researches can be carried out parallely. Through this kind of mixed method approaches, various compartments, consisting acupuncture treatment effects are able to be revealed totally.
In this context, the investigators designed a multi-center randomized controlled trial, comparing acupuncture treatment and artificial tear drop with immunoassay for the change of tear cytokine concentration, cost effectiveness study and qualitative research in a mixed method approach.
Participants, allocated to this group, will have twelve times of acupuncture treatment in four weeks. Seventeen acupuncture points, which are both BL2, GB14, TE23, Ex1, ST1, GB20, LI4, LI11 and single GV23, will be selected and disposable 0.20*30mm acupuncture needles(Dongbang Co., Korea) will be inserted on these points. Strong 'deqi' sensation will be induced by twisting acupuncture needles and retained for 20 minutes before removed.
Participants, allocated to this group, will be offered preservative-free and single-use Refresh plus (Sodium carboxymethylcellulose). They should use artificial tear in both eyes at least once a day for four weeks.
Inclusion Criteria: Patients who have had dry eye syndromes in single eye or in both eyes (ICD-10 : H04.1). He or she must have both of the conditions below: Patients who have dry eye symptoms such as itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec. Exclusion Criteria: Patients who have defects of the eyelid or eyelashes Acute infection of the eyelid, eyeball or eye accessories Stevens-Johnson syndrome Vitamin A deficiency Eye or accessory defects due to external injuries A past history of surgical operation related to the eye in last three months Punctual occlusion Current usage of contact lenses Sequelae of facial palsy, Current usage of anti-inflammatory eye drops in the last two weeks Pregnancy Using history of traditional medicinal treatment such as acupuncture, moxibustion and herbal medicine in the last one month
