Dry eye disease
Conditions
Interventions
Fu's Subcutaneous Needling group:Fu's Subcutaneous Needling
Placebo Fu's Subcutaneous Needling group:Placebo Fu's Subcutaneous Needling
Sponsors
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1)Age between 18-65 years old, male or female. 2)Patients meet the criteria of the Expert Consensus on Dry Eye in China: Definition and Classification (2020) in a single eye or in both eyes on the following ophthalmic test results: Patients who have dryness, foreign body sensation, burning, visual fatigue, ocular redness and blurred vision with ocular surface disease index (OSDI)=13. Simultaneously, fluorescein breakup time (FBUT) =5s, or noninvasive breakup time (NIBUT) <10s, or Schirmer-I test (SIT) (without anesthesia) value = 5 mm/5 min. Or patients with dry eye syndrome score OSDI=13. And FBUT between 5s and 10s, or a SIT value between 5 mm/5 min and 10mm/5 min, and corneal fuorescein staining (CFS) scale=5 points. 3)Intraocular pressure ranges from 10 to 21mmHg. 4)Patients voluntarily to receive FSN treatment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Eye structure changes such as corneal ulcer, atresia of lacrimal gland opening, complete atrophy of accessory lacrimal gland, eyelid relaxation, etc. Diseases with unclear interstitial diopter, such as cataract; Fundus lesions such as macular edema, diabetic retinopathy, etc. Or with other eye diseases such as glaucoma, optic nerve disease, allergic conjunctivitis, etc. 2)Patients who have undergone ophthalmic surgery within the last six months. 3)Take medications which lead to dry eye such as isotretinoin and antidepressants. 4) Use of other medications for dry eye, wear contact lenses or corneal contact lens in the past week. 5) Patients with Sjogren's syndrome, facial palsy, thyroid eye disease, vitamin A deficiency, goiter, coagulation disorders, local skin infection, severe diseases and such as heart, cerebrovascular, liver and kidney and hematopoietic system. 6) Pregnant or lactating women. 7) Those who refuse Fu’s subcutaneous needling. 8) Patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface disease index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Breakup time of tear film;Schirmer test I ;tear meniscus height.;Red eye index;Corneal fluorescein staining;Ultrasound;Optical coherence tomography angiography;Pain pressure threshold;Cervical range of motion;Hamilton anxiety scale; | — |
Countries
China
Contacts
Public ContactYong Sun
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed