Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- cornea nerves
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.
干预措施: Autologous serum tears combined with 0.05% cyclosporin eye drop (Drug)
结局指标
主要结局
cornea nerves
时间窗: 12 weeks
cornea sub-basal nerve density
cornea staining score
时间窗: 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）
次要结局
- Schirmer's test(4 weeks)
- Ocular Surface Disease Index (OSDI)(4 weeks)
- tear film breakup time (TBUT)(4 weeks)
研究者
Jiachun Hu
Resident physician
Chengdu University of Traditional Chinese Medicine