The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Schirmer Testing
Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production.
Time frame: Immediately following the procedure (ie immediately following use of the device)
Clinically Significant Changes in Visual Acuity
Clinically significant change in Best corrected visual acuity (BCVA)- this measurement was taken to determine if a significant change in BCVA was noted for participants. If a clinically significant change was noted (greater or equal to 2 lines of vision) then a subject would be listed in the data table below.
Time frame: Immediately following the procedure (ie immediately following use of the device)
Clinically Significant Changes in Slit Lamp Exam
Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.
Time frame: Immediately following the procedure (ie immediately following use of the device)
Number of Adverse Events
Pain, headache, nosebleed, etc felt to be associated with use of the device
Time frame: Immediately following the procedure (ie immediately following use of the device)
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