Dry Eye
Conditions
Keywords
Dry eye, Laser acupuncture, Traditional Chinese medicine
Brief summary
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.
Detailed description
Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye. Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
Interventions
PROCEDURELaser acupuncture
Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
PROCEDURESham laser acupuncture
Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sham laser acupuncture: laser acupuncture without laser output.
Intervention model description
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 20 \< age \< 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent. * Tear film break-up time \< 10 s * Schirmer's strips with anesthesia \< 5mm/ 5min
Exclusion criteria
* presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens * pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis * critical illness such as Stevens-Johnson syndrome, etc * has taken or needs active treatment (including Chinese medicine) * presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin * does not meet the physician's assessment for recruitment * lack of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index | 12 weeks | The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer test | 12 weeks | A Schirmer's test is used to assess how quickly the eyes produce tears. |
| Visual analogue scale of eye discomfort | 12 weeks | A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort. |
| Tear film break-up time | 12 weeks | Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking. |
Countries
Taiwan
Contacts
Primary ContactWen-Long Hu, MD, MS
Outcome results
None listed