Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- meibomian gland function
研究概览
简要总结
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All the subjects are female and age between 50-60 years
- •Patients with primary SS fulfilled the criteria established by the European Study Group
- •Patients with SLE and RA met the criteria set by the American College of Rheumatology
排除标准
- •The control history of autoimmune disease
研究组 & 干预措施
secondary Sjögren's syndrome
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
干预措施: Tears Naturale Forte (Drug)
primary Sjögren's syndrome
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
干预措施: liposic (Drug)
primary Sjögren's syndrome
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
干预措施: Tears Naturale Forte (Drug)
secondary Sjögren's syndrome
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
干预措施: liposic (Drug)
meibomian gland dysfunction
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
干预措施: liposic (Drug)
meibomian gland dysfunction
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
干预措施: Tears Naturale Forte (Drug)
control
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
干预措施: liposic (Drug)
control
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
干预措施: Tears Naturale Forte (Drug)
结局指标
主要结局
meibomian gland function
时间窗: up to 3 months after tear substitutes apply
assessment of the quality of meibomian gland secretions, according to a published classification system (21). In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression.
Ocular Surface Disease Index
时间窗: up to 3 months after tear substitutes apply
The OSDI questionnaire is used to quantify the dry eye symptoms. Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers. Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms. Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
noninvasive tear breakup time
时间窗: up to 3 months after tear substitutes apply
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other. The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination. An illuminated ring pattern was then projected onto the cornea. At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible. Irregularities in the reflected image will be observed closely. Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur. The examination will be recorded on video.
fluorescein staining of the cornea
时间窗: up to 3 months after tear substitutes apply
Upper, lower, nasal, temporal and central quadrants were used. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, \<5 punctuate stains; 2, \>5 punctuate stains but \<10; and 3, \>10 or filamentous staining detected. The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
Schirmer's test with and without anesthesia
时间窗: up to 3 months after tear substitutes apply
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin. Schirmer test strips will remain in place for 5 minutes with the eyes closed. The extent of wetting will be subsequently measured according to the scale provided by the manufacturer. Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
次要结局
- tear meniscus(up to 3 months after tear substitutes apply)
- rose bengal staining of the conjunctiva(up to 3 months after tear substitutes apply)
研究者
Jingmin Yuan, MD
MD
LanZhou University
