SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
Stopped early · Not applicable
Conditions studied: Epiphora, Dacryocystorhinostomy
In brief
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.
Key facts
- Study ID
- NCT03705000
- Run by
- Thomas Gardner
- People needed
- 5
- Starts
- 2020-10-16
- Expected to finish
- 2022-05-11
- Last updated by the study team
- 2026-02-25
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
- Eligible for unilateral DCR surgery with stenting for treatment of epiphora secondary to nasolacrimal duct obstruction.Ability to instill post-operative eye drop
- Signed written, informed consent.
You may not qualify if…
- Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
- Subjects scheduled for bilateral DCR surgery
- Subjects with known sensitivity to silicone
- Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
- Inability to use eye drops
- Subjects with a known sensitivity to required study medications (e.g. antibiotic drops) if an alternative medication is not available.
Where it is running
- Kellogg Eye Center, 1000 Wall Street — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.