Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072, China
NCT Number: NCT06013436
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.
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Notify Me18 year–65 year
All sexes
Observational
Chengdu, Sichuan, 610072, China
Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves.
Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients administrated autologous serum tears twelve times daily(per hour) and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.
Other names: Ciclosporin Eye Drops(II)(Cyclone® ,SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.)
Time frame: 12 weeks
cornea sub-basal nerve density
Time frame: 4 weeks
to evaluate corneal epithelial repair(0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30)
Time frame: 4 weeks
to assess the quality of life and clinical symptom;The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)
Time frame: 4 weeks
to assess tear flow
Time frame: 4 weeks
to assess tear film stability
Chengdu University of Traditional Chinese Medicine
Other
Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye
Acronym: AST/SS
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