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

NCT03705000 | Terminated Results FDA Device

• 1 other identifier: HUM00114919
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety, as Measured by Number of Subjects With at Least One Adverse Event

  Adverse events will be recorded from the time of surgical implantation of the device until the final visit. Ophthalmic complications or adverse events that are observed by the investigator or reported by the subject will be recorded on the CRFs. For all adverse effects, sufficient information will be pursued and/or obtained so as to permit 1) an adequate determination of the outcome of the effect (i.e., whether the effect should be classified as a serious adverse effect) and; 2) an assessment of the causal relationship between the adverse effect and the investigational device or, if applicable, the other study treatment or diagnostic product(s).

  Surgery to final exit visit (Month 4-7)

Secondary Outcomes (2)

• Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)

  1-4 month post-operative follow-up visit

• Lac-Q Score

  1-4 months post operative

Study Arms (2)

Slit Stent II

EXPERIMENTAL

The Slit Stent II (investigational) device is created by modifying an existing FDA cleared lacrimal stent (BIKA, manufactured by FCI Opthalmics) by adding additional 3 mm and 35 mm long slits of equal depth.

Device: Slit Stent II

BIKA for DCR

ACTIVE COMPARATOR

The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.

Device: BIKA for DCR

Interventions

Slit Stent II DEVICE

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.

Also known as: Lacrimal Stent

Slit Stent II

BIKA for DCR DEVICE

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

Also known as: stent

BIKA for DCR

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Thomas Gardner: lead

Study Sites (1)

Kellogg Eye Center, 1000 Wall Street

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Interventions

Dacryocystorhinostomy; Stents

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ostomy; Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Thomas Gardner, MD
• Organization: University of Michigan

tomwgard@med.umich.edu

734 232-8404

Study Officials

• Thomas Gardner, MD, MS

  University of Michigan Kellogg Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology and Visual Science and Molecular and Integrative Physiology

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: October 16, 2020
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)