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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Autologous serum tears, twelve times daily(per hour), 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous serum tears combined with 0.05% cyclosporin eye drop | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cornea nerves | cornea sub-basal nerve density | 12 weeks |
| cornea staining score | 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 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) | 4 weeks |
| Schirmer's test |
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Inclusion Criteria:
Exclusion Criteria:
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From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome were treated in the Department of Ophthalmology and Rheumatology and Immunology of the Hospital of Chengdu University of Traditional Chinese Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Jiachun Hu, Resident | Chengdu University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610072 | China |
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|
to assess tear flow
| 4 weeks |
| tear film breakup time (TBUT) | to assess tear film stability | 4 weeks |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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