Dry Eye, Ocular Surface Disease, Sjogren's Syndrome
Conditions
Keywords
autologous serum tears, 0.05% cyclosporin eye drop, cornea nerves
Brief summary
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.
Detailed description
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.
Interventions
DRUGAutologous serum tears combined with 0.05% cyclosporin eye drop
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.
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts. * Age 18-65 years old. * Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial. * At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids.
Exclusion criteria
* Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS. * Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases. * Those who have a history of previous ocular oprations, eye injuries or contact lenses usage. * Known hypersensitivity to experimental drugs or any of its ingredients. * Necessity to modify the systemic treatment of previous diseases during the trial. * Pregnancy or lactation. * Severe systemic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cornea nerves | 12 weeks | cornea sub-basal nerve density |
| cornea staining score | 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） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 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) |
| Schirmer's test | 4 weeks | to assess tear flow |
| tear film breakup time (TBUT) | 4 weeks | to assess tear film stability |
Countries
China
Outcome results
None listed