dry eye after phacoemulsification
Conditions
Interventions
Trial group:Usage of 0.05% cyclosporin eye drops twice a day
Control group:Usage of 0.1% sodium hyaluronate eye drops four times a day
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) More than 50 years old, age-related cataract OU, Patients are with no previous history of ocular surgery and no Sjogren's syndrome; 2) The patient is diagnosed with cataract by relevant examination (slit lamp, anterior segment photography, fundus photography, OCT, ERG, etc.). The patient is willing to perform phacoemulsification combined with intraocular lens implantation under anesthesia; 3) According to the criteria in 2016, diagnosis of dry eye is established after cataract surgery (OSDI total score> 13 points and TBUT 5 seconds); 4) After the patient received a complete explanation of their participation in the study and full knowledge of the study, voluntary written consent to participate in this study is obtained and the patient should complete all required visits; 5) No history of coronary heart disease, no history of cerebrovascular disease, no history of alcoholism and smoking, and normal coagulation function.
Exclusion criteria
Exclusion criteria: 1) patients diagnosed with dry eye even before cataract surgery; 2) patients with active eye infection, Patients with corneal erosion; 3) irritation of the cornea and conjunctiva due to eyelashes, tears or conjunctival laxity; 4) from the start of the screening test to the end of the study drug administration, Patients who cannot or will be unable to stop other eye drops and drugs listed as prohibited concomitant drugs (including all prescription and OTC drugs); 5) from the start of the screening test and the last administration of eye drops, Patients who could not stop using contact lenses during the inclusion period; 6) patients with a history of corneal refractive surgery; 7) patients who were allergic to the study drug and reagent components; 8) patients who received dry eye medication within the first 6 months; 9) patients using glaucoma eye drops.10) with insomnia, Depressed patients, Central nervous system suppression patients, And other patients of mental diseases; Patients with myasthenia gravis, Patients with ADHD; 11) experienced cardiovascular events such as stroke, cerebral ischemia, and myocardial infarction within 6 months before screening; 12) patients with systemic diseases, Such as diabetes, thyroid disease, autoimmune disease, and atopic dermatitis; 13) target eye or systemic presence of putting the subject in high risk if continued participation in the study (such as malignant hypertension, Aids, therioma, Serious mental, cardiovascular, nervous, respiratory, digestive and other system diseases, Or the long-term use of hormones, Immunodeficiency diseases, After cardiac stenting, After organ transplantation, etc.); 14) the investigator is not suitable to participate in the trial during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| breakup time of tear film (BUT);Schirmer test;Corneal staining score; | — |
Countries
China
Contacts
Public ContactQiaoyun Gong
Shanghai General Hospital
Outcome results
None listed