Acupuncture for Dry Eye

Last updated: January 7, 2011
Sponsor: Korea Institute of Oriental Medicine
Overall Status: Completed

Phase

3

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT01105221
KI1001
  • Ages 19-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 bodysensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensationof photophobia, ocular redness, sensation of tearing

  2. Patients whose tear film break-up time is below 10 seconds and Schirmer I testresults is below 10mm/5sec.

Exclusion

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 andherbal medicine in the last one month

Study Design

Total Participants: 150
Study Start date:
April 01, 2010
Estimated Completion Date:
January 31, 2011

Study 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.

Connect with a study center

  • Clinical Research Center of DongGuk Univ. Internaltional Hospital

    Goyang, Gyeonggi 410-773
    Korea, Republic of

    Site Not Available

  • Clinical Research Center of Korea Institute of Oriental Medicine

    Daejeon, 301-724
    Korea, Republic of

    Site Not Available

  • Clinical Research Center of DongShin Univ. Oriental Hospital

    Gwangju, 503-232
    Korea, Republic of

    Site Not Available

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