dry eye
Conditions
Interventions
treatment:1) 1-2 drops of topical anesthetic eye drops were applied to the eyes of patients to relieve the discomfort and irritation during the procedure.
2) Lacrimal duct irrigation: saline was used
Sponsors
Eye, Ear, Nose, and Throat Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes aged between 18 and 75 years; 2. Written informed consent; 3. Patients with clinical symptoms and signs of dry eye, according to the Chinese dry eye consensus, meet any of the following diagnostic criteria: 1) with any of the symptoms (dry eye, foreign body sensation, burning sensation, eye fatigue, discomfort, visual acuity fluctuation and other subjective symptoms) and tear film break-up time =5 s or schirmer test (without anesthetic)=5 mm/5 min; 2) with any of the symptoms (dry eye, foreign body sensation, burning sensation, eye fatigue, discomfort, visual acuity fluctuation and other subjective symptoms), 5 s< tear break-up time =10 s, 5 mm/5 min< schirmer's test (without anesthetic)=10 mm/5 min, and positive corneal fluorescein staining. 4. The patient is not currently receiving dry eye treatment (within 30 days before screening). Currently using (or within 30 days before screening) OTC artificial tears, or eye gels, is acceptable. 5. Able and willing to participate in all trial assessments and visits as directed.
Exclusion criteria
Exclusion criteria: 1. The lacrimal system has inflammation, infection, stenosis, or obstruction; 2. Sjogren's syndrome or other autoimmune diseases; 3. Ongoing (within 30 days before screening) dry eye treatment other than OTC artificial tears, including prescribed eye drops (cyclosporine, diquafosol, steroid, etc.), meibomian gland treatment (meibomian gland expression, intense pulsed light, etc.); (4) patients who received permanent lacrimal duct embolization, or patients who received degradable lacrimal duct embolization within 6 months); 5. History of eye surgery within 6 months before screening; 6. Anterior segment active diseases (such as keratoconjunctival infection, keratitis), periocular malignant tumors and glaucoma; 7. Anatomical abnormalities of the eyelids (e.g. dysraphism, entropion or ectropion) or abnormal blinking; 8. Dry eye diseases secondary to scar formation, such as alkali burn, cicatricial pemphigus, conjunctival goblet cell destruction, etc. 9. Women who are pregnant, breastfeeding or planning to become pregnant; 10. Complicated with uncontrolled systemic diseases; 11. Use of any medications known to cause dry eye (e.g., antihistamines or antidepressants) within 30 days before screening or anticipate irregular use of oral medications that cause dry eye during the trial; 12. Ongoing drug or clinical device trials; 13. Any circumstances considered by the investigator to be inappropriate for participation in the trial 14. Women who are pregnant, breastfeeding or planning to become pregnant; 15. Complicated with uncontrolled systemic diseases; 16. Ongoing drug or clinical device trials; 17. Have used any medications known to cause dry eye (e.g., antihistamines or antidepressants) within 30 days before screening or are expected to use oral medications that cause dry eye irregularly during the trial; 18. Any circumstances that the investigator considers inappropriate for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phenol red thread test (PRT test); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular surface disease index (OSDI);Tear breakup time (TBUT);Corneal fluorescein staining (CFS) (NEI scale); | — |
Countries
China
Contacts
Public ContactGong Lan
Eye, Ear, Nose, and Throat Hospital of Fudan University
Outcome results
None listed