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Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03434106
Enrollment
60
Registered
2018-02-15
Start date
2018-02-10
Completion date
2018-06-30
Last updated
2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction, Sjögren's Syndrome

Keywords

meibomian gland dysfunction, Sjögren's syndrome, dry eye disease

Brief 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.

Interventions

Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatmen

This medication is used to relieve dry, irritated eyes

Sponsors

LanZhou University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
meibomian gland functionup to 3 months after tear substitutes applyassessment 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.
noninvasive tear breakup timeup to 3 months after tear substitutes applyFour 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.
Schirmer's test with and without anesthesiaup to 3 months after tear substitutes applyThe 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.
Ocular Surface Disease Indexup to 3 months after tear substitutes applyThe 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
fluorescein staining of the corneaup to 3 months after tear substitutes applyUpper, 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).

Secondary

MeasureTime frameDescription
rose bengal staining of the conjunctivaup to 3 months after tear substitutes applyrose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea.
tear meniscusup to 3 months after tear substitutes applyThe 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.

Countries

China

Contacts

Primary ContactJingmin Yuan, MD
15002626556@163.com+(86)15002626556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026