Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.
Up to 10 patients will be enrolled and followed for six months. The primary objective is to demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. The primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
Stanford University
Stanford, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Center for Sight
Sarasota, Florida, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing.
PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline
Time frame: Six Months
Measurement of device insertion success
Time frame: Procedural
Evaluation of all safety
Recording of all safety events that occur in the first six months of treatment
Time frame: Six Months
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