SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction

Summary

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.

Conditions

• Epiphora
• Dacryocystorhinostomy

Interventions

DEVICE

Slit Stent II

The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.

DEVICE

BIKA for DCR

The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device

Sponsors & Collaborators

• Thomas Gardner

  lead OTHER

Principal Investigators

• Thomas Gardner, MD, MS · University of Michigan Kellogg Eye Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-16

Primary Completion

2022-05-11

Completion

2022-05-11

FDA Device

Yes

Countries

• United States

Study Locations