Autoimmune disease related dry eye
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70, regardless of gender. (2) Participants suffer from autoimmune diseases that meet the ACR/EULAR diagnostic criteria, including rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, ankylosing spondylitis, and systemic sclerosis. (3) Patients diagnosed with dry eye disease according to the "Chinese Expert Consensus on Dry Eye (2020)". (4) Participants will undergo screening diagnosis and follow-up activities at our center. (5) BCVA = 0.6. (6) The average of three IOP measurements during screening = 21 mmHg. (7) Participants willing to discontinue wearing contact lenses during the study period. (8) Subjective cooperation and participants are able to sign a written informed consent form. A signed, dated informed consent form is required, indicating that the patient (or a legal representative) has been informed of all relevant information about the study.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following criteria were not eligible for inclusion in the study: (1) Previous history of diabetes, hyperlipidemia, AIDS, sarcoidosis et al. (2) Patients with previous hematopoietic stem cell transplantation (3) Unable to complete the ocular surface disease index (OSDI) questionnaire (4) History of ocular surgery within 6 months before screening (5) Ocular surface dystrophy or infection, systemic treatment with drugs with corneal toxicity (6) History of cataract, glaucoma and other eye diseases affecting vision (7) Except from anti-infective drugs, systemic or topical immunosuppressive agents/corticosteroids, using of other drugs that may affect the ocular surface during treatment, such as oral analgesics, antidepressants, antipsychotic drugs, anti-Parkinson drugs, antihistamines, estrogen derivatives, and topical anti-glaucoma eye drops.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index;Tear film quality and ocular surface conditions;Tear fluid inflammatory cytokines; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conjunctival biomarkers;Ocular surface microorganism; | — |
Countries
China
Contacts
Department of Ophthalmology, Renji Hospital, Shanghai Jiao Tong University School of Medicine