dry eye
Conditions
Interventions
non-dry eye group:N/A
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: experience group: 1. Volunteer to participate in this clinical study and sign the informed consent form; 2. Sex unlimited, age 18-70; 3. There are clinical symptoms and signs of dry eye, and the clinical examination conforms to one of the diagnostic criteria of "Dry Eye Expert Consensus" (as follows): 1) One of the subjective symptoms, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation, and BUT = 5 seconds or Schirmer I test (without surface anesthesia) = 5 mm/5 min; 2) When one of the subjective symptoms, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation, and 5 < BUT = 10 seconds or 5 < Schirmer I test (without surface anesthesia) = 10mm/5min, there is also positive staining of keratoconjunctiva fluorescein; 4. Corneal fluorescein has no staining or spot staining can be counted (and the staining number is = 30 points) and conjunctival fluorescein staining is 0-III grade; 5. Choice of study eyes: both eyes of the patients were examined, and the eyes with high symptom and sign scores were taken as the study eyes; If the scores are equal, the eye with severe corneal fluorescein staining is taken as the study eye; if the fluorescein staining degree of both eyes is equal, the right eye is taken as the study eye; 6. No clinical trials of other drugs have been conducted within 2 weeks of the trial. Control group: 1. Volunteer to participate in this clinical study and sign the informed consent form; 2. Sex unlimited, age 18-70; 3. The clinical symptoms and signs of dry eye and the clinical examination did not meet the diagnostic criteria of Dry Eye Expert Consensus.
Exclusion criteria
Exclusion criteria: 1. At visit 0 and visit 1, there were obvious abnormalities in slit lamp microscopy and/or the researcher's judgment might affect the evaluation of test indicators, including eye trauma and history of eye trauma; 2. Have a medical history of Steven Johnson; 3. Within 6 months before Visit 1, LipiFlow treatment or any other treatment that affects the meibomian gland was performed; 4. The anatomical structure of the eyelid is abnormal, which leads to the insufficiency of eyelid closure, including entropion and ectropion or eyelid laxity syndrome, thus exposing part of the conjunctiva or damaging the blink function of the eyes; Dry eye secondary to scar, radiation, alkali burn, cicatricial pemphigoid or conjunctival goblet cell damage (such as lack of vitamin A); 5. Eye or periocular malignant tumor; Corneal epithelial defect, obvious fusion of corneal staining or filamentous material on cornea; Have a history of herpetic keratitis; Active eye allergy or possible eye allergy during the test; 6. Be diagnosed with persistent eye or systemic infection (bacteria, viruses or fungi), including fever or being treated with antibiotics; 7. Have undergone intraocular surgery or intraocular laser surgery in the past 6 months, or have planned to perform any eye and/or eyelid surgery during the test period; 8. The researcher believes that the patient has uncontrollable systemic diseases; 9. Have used any known oral drugs (such as antihistamines, antidepressants, etc.) that may cause eye dryness within 1 month before the visit, or it is expected that oral drugs that may cause eye dryness will be used irregularly during the test; 10. It is possible or in a situation (including language disorder) that the researcher thinks may cause the subject to face significant risks, confuse the test results or seriously interfere with the subject's participation in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer test;Corneal fluorescein sodium staining;Tear film rupture time; | — |
Countries
China
Contacts
Public ContactLei Tian
beijing tongren hospital
Outcome results
None listed