Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

Meibomian Gland Dysfunction Clinical Trial

Official title:

Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060005
• Other study ID #: 2017DHLL001
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2017
• Last updated: May 14, 2017
• Start date: May 1, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: May 2017
• Source: Tung Wah Hospital
• Contact: Chi Zhang, MD,PhD
• Phone: +8613790077756
• Email: mike0946[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• The control history of autoimmune disease

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Drug:
• Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
• liposic
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatment of the symptoms of dry eye.

Locations

Country	Name	City	State
China	Tungwah Hospital of Sun Yat-sen University	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Tung Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meibomian gland function	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	up to 3 months after tear substitutes apply
Primary	Ocular Surface Disease Index	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	up to 3 months after tear substitutes apply
Primary	noninvasive tear breakup time	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.	up to 3 months after tear substitutes apply
Primary	fluorescein staining of the cornea	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).	up to 3 months after tear substitutes apply
Primary	Schirmer's test with and without anesthesia	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.	up to 3 months after tear substitutes apply
Primary	tear meniscus	The subject will be asked to blink her eyes once ,then the image of tear meniscus height will be captured by a Keratograph 5 (Oculus, Wetzlar, Germany).After that tear meniscus height will be measured at the centre of the lower lid margin. This performance will be taken three times and the average value will be recorded.	up to 3 months after tear substitutes apply
Secondary	rose bengal staining of the conjunctiva	) rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea	up to 3 months after tear substitutes apply