Stopped: One PI left UMichigan in 2020. another continued the work between 2020 and 2022, and left; the intention was to determine a PI to resume the trial. After a period of time, the decision was made to close the trial.
This project aims to test whether a newly designed lacrimal stent - the SlitStent - when placed into the lacrimal system in the standard fashion following a DCR surgery, will provide good symptomatic relief for epiphora and be well tolerated. Epiphora, or severe tearing, is both a very common debilitating symptom and a potential cause of dangerous infections (i.e. dacryocystitis and orbital cellulitis). DCR+lacrimal stenting surgery is 80-95% successful at improving epiphora, and the longer the stent remains in place, the better the long-term outcome. However, lacrimal stents that provide adequate circumferential force to facilitate post-DCR healing also occupy space and prevent good tear drainage until removed. Yet patients want complete symptomatic improvement as soon as possible, even if it compromises long-term results. This study aims to test a newly designed lacrimal stent that allows tears to drain through the lumen of the stent. The new stent is constructed by modifying a commercially available stent by placing openings along the side of the stent using a process developed by a University of Michigan engineer/collaborator. Following slit placement, the stent will be gas-sterilized for surgery. Patient who are scheduled for DCR+stenting surgery who provide informed consent will be randomized 2:1 to receive the investigational SlitStent or the standard commercially available stent. Following surgery, patients will be assessed both clinically, which is standard of care, and via a patient questionnaire.
Age range
22 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety, as Measured by Number of Subjects With at Least One Adverse Event
Timeframe: Surgery to final exit visit (Month 4-7)