Acupuncture for Dry Eye

Korea Institute of Oriental Medicine

Status and phase

Completed

Phase 3

Conditions

Dry Eye

Treatments

Device: Acupuncture

Drug: Refresh Plus

Study type

Interventional

Funder types

Other

Identifiers

NCT01105221

KI1001

Details and patient eligibility

About

The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.

Full description

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.

Enrollment

150 estimated patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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:
1. 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
2. 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