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临床试验/NCT03434106
NCT03434106Unknown不适用

Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

LanZhou University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月10日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Experimental

The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.

干预措施: liposic (Drug)

meibomian gland dysfunction

Experimental

The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.

干预措施: liposic (Drug)

meibomian gland dysfunction

Experimental

The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.

干预措施: Tears Naturale Forte (Drug)

control

Experimental

the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.

干预措施: liposic (Drug)

control

Experimental

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

发起方
LanZhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingmin Yuan, MD

MD

LanZhou University

研究点 (1)

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