Dry Eye
Conditions
Keywords
Acupuncture treatment, Dry Eye Acupoint Therapeutic Instrument, Safety, Validity
Brief summary
To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.
Interventions
DEVICEdry eye acupoint therapy instrument
The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.
DRUGArtificial tear
0.3% Ali eye drops
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who meet the diagnostic criteria for dry eye: The diagnostic and classification criteria refer to the Consensus of Chinese dry eye Experts: Definition and Classification (2020); 2. this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment; 3. this research project, informed consent and signed informed consent form, participants are willing to accept treatment. Those who met the above criteria could be included in the study.
Exclusion criteria
1. Patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma; 2. Those who have undergone external or internal eye surgery in the past 6 months； 3. Patients who have undergone tear punctum embolization or submandibular gland transplantation; 4. Wearing contact lenses within the past 3 months； （5）History of ocular trauma; （6）Active fundus lesions in the past 3 months； （7）People who are allergic to artificial tears; （8）Suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism; (9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's test (SLT) | baseline and 8 weeks post-treatment | The Schirmer test uses filter paper to wick up tears and measure the amount of production. |
| Tear film breakup time (TBUT) | baseline and 8 weeks post-treatment | The time interval between keeping eyes open after blinking until the first dry spot appears on the tear film surface is one of the important criteria to evaluate the stability of tear film. |
| Ocular Surface Disease Index, OSDI | baseline and 8 weeks post-treatment | The most commonly used questionnaire in clinical diagnosis of dry eye. It is mainly used to diagnose dry eye and assess the severity of the condition |
| Corneal fluorescein staining (CFS) | baseline and 8 weeks post-treatment | Corneal fluorescein staining (CFS) is a valuable clinical tool to assess the viability of the epithelium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MGD | baseline and 8 weeks post-treatment | Meibomian Gland (MG) expressibility and secretion quality |
Countries
China
Outcome results
None listed