Keratoconjunctivitis Sicca, Xeropthalmia
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of acupuncture in the treatment of moderate to severe dry eye by replicating the study design of the previous protocol and to see the study through to its completion.
Interventions
PROCEDUREAcupuncture
Needles placed bilaterally on the ears at the auriculotherapy points. Additional needles placed in both index fingers. A third set of needles inserted on both index fingers between LI-1 adn LI-2.
PROCEDURESham acupuncture
Four needles will be placed on the left and right upper shoulder areas. Small circular adhesive tape will be placed in an ear area, but not on the acupuncture points.
Sponsors
Malcolm Grow Medical Clinics and Surgery Center
Walter Reed Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Military healthcare beneficiary * Male and female patients, at least 18 years of age * Diagnosis of keratoconjunctivitis sicca or xerophthalmia (dry eyes) in one or both eyes * Persistent signs and symptoms despite conventional therapy for at least three months
Exclusion criteria
* Contact lens wear * Intraocular surgery or laser in the study eye within 90 days prior to enrolling in the study * History of any medical condition or circumstance that would preclude scheduled visits or completion of the study * Known history of adverse reaction to acupuncture * Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To answer the question of whether there are objective beneficial effects of an acupuncture treatment versus sham acupuncture on dry eye, as measured by some of the most widely-used clinical indicators in the literature. | 6 months after acupuncture or sham acupuncture treatment |
Countries
United States
Outcome results
None listed