SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 12/23/2018 |
| Start Date: | January 20, 2019 |
| End Date: | December 31, 2020 |
| Contact: | Munira Hussain, MS |
| Email: | hussain@med.umich.edu |
| Phone: | 734-647-8397 |
Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
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.
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.
This is a single center study that will be conducted at the University of Michigan (Ann
Arbor, Michigan). Fifteen (15) subjects will be enrolled and treated with either the
experimental Slit Stent II or the control stent BIKA for DCR. Patients who are currently
scheduled to undergo a DCR (dacryocystorhinostomy) as per standard of care will be offered
participation in the study. Patients who elect to participate in the study will be consented
and then randomized to the treatment or control arm.
A lacrimal stent is hollow silicone tubing with a non-traumatic tip. The tubing is securely
attached into malleable stainless steel probes that are used to guide the silicone tubing
through the lacrimal drainage apparatus. The device is used to maintain an open lacrimal path
between the surface of the eye and the nasal passages, particularly during a healing process
following injury or surgery.
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 lacrimal stent consists of a single unit including a silicone tube (length: 280 mm,
external diameter: 0.94 mm), and one steel probe at each end of the silicone tube (length: 53
mm, external diameter: 0.8 mm) with round tips.
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
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.
The axial cutouts located on the stent allow drainage of tears from the ocular surface to the
nasal/oropharynx cavities through the internal lumen of the stent.
All modifications to the stent are inspected under an optical microscope at a magnification
of at least 5x to ensure they are free from cutting defects, which could impact the
structural integrity of the Slit Stent II. To ensure that the Slit Stent II can withstand the
forces experienced during implantation and removal, additional mechanical integrity tests
were performed. Comparing the implantation forces to the maximum insertion and removal force,
it was determined that the modified Slit Stent II will have excellent tensile strength -
essentially identical to unmodified stent - to prevent mechanical failure in patient use.
Each section was tested to determine the maximum elongation and force it can withstand before
failure.
The study duration will be 6 months for all study patients.
The following examination schedule will be followed from screening through the postoperative
visits:
- Screening (Day -60 to Day 0 Preoperatively)
- Device implantation operation
- Phone call Assessment at 1 day post op
- Phone call Assessment at 45 days post op (+/- 15 days)
- Day 5-14 postoperatively
- Day 30-120 postoperatively (with stent removal)
- 4-7 month final post-operative exam
Subjects will be randomly assigned to the experimental vs. control stents using a randomized
block design with 2:1 allocation to treatment and control. Stents will be provided to the
surgical team on the day of surgery by the Study Coordinator. Surgical team, recruitment
staff, and scheduling staff will be masked to treatment assignment until day of surgery. All
tests and measurements should be obtained in accordance with the procedures specified in this
protocol. If it is not possible to perform a measurement or examination due to the individual
eye's specific ocular pathology, the reason for not performing the test or measurement should
be documented on the source documents.
The investigator may designate one or more surgeon sub-investigators at his/her investigative
site. A surgeon sub-investigator may evaluate subjects for the study and perform the Slit
Stent II lacrimal stent intubation. Surgeon sub-investigators will be listed on all
applicable investigator regulatory documents (including the delegation of responsibilities
log) and will complete all sponsor-required training for the study.
For the two post-op study visits, the Quality of Life (QOL) questionnaire (Glasgow Benefit
Inventory (GBI)- see Appendix A) and the Patient Tearing Questionnaire (Munk Scale and Lac-Q
questionnaire, see Appendix B) will be administered by an interviewer, and the interviewer
will record the subject's responses directly onto the corresponding questionnaire CRFs or
source documents and calculate the GBI score, Munk Score, and Lac-Q score.
Arbor, Michigan). Fifteen (15) subjects will be enrolled and treated with either the
experimental Slit Stent II or the control stent BIKA for DCR. Patients who are currently
scheduled to undergo a DCR (dacryocystorhinostomy) as per standard of care will be offered
participation in the study. Patients who elect to participate in the study will be consented
and then randomized to the treatment or control arm.
A lacrimal stent is hollow silicone tubing with a non-traumatic tip. The tubing is securely
attached into malleable stainless steel probes that are used to guide the silicone tubing
through the lacrimal drainage apparatus. The device is used to maintain an open lacrimal path
between the surface of the eye and the nasal passages, particularly during a healing process
following injury or surgery.
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 lacrimal stent consists of a single unit including a silicone tube (length: 280 mm,
external diameter: 0.94 mm), and one steel probe at each end of the silicone tube (length: 53
mm, external diameter: 0.8 mm) with round tips.
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.
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.
The axial cutouts located on the stent allow drainage of tears from the ocular surface to the
nasal/oropharynx cavities through the internal lumen of the stent.
All modifications to the stent are inspected under an optical microscope at a magnification
of at least 5x to ensure they are free from cutting defects, which could impact the
structural integrity of the Slit Stent II. To ensure that the Slit Stent II can withstand the
forces experienced during implantation and removal, additional mechanical integrity tests
were performed. Comparing the implantation forces to the maximum insertion and removal force,
it was determined that the modified Slit Stent II will have excellent tensile strength -
essentially identical to unmodified stent - to prevent mechanical failure in patient use.
Each section was tested to determine the maximum elongation and force it can withstand before
failure.
The study duration will be 6 months for all study patients.
The following examination schedule will be followed from screening through the postoperative
visits:
- Screening (Day -60 to Day 0 Preoperatively)
- Device implantation operation
- Phone call Assessment at 1 day post op
- Phone call Assessment at 45 days post op (+/- 15 days)
- Day 5-14 postoperatively
- Day 30-120 postoperatively (with stent removal)
- 4-7 month final post-operative exam
Subjects will be randomly assigned to the experimental vs. control stents using a randomized
block design with 2:1 allocation to treatment and control. Stents will be provided to the
surgical team on the day of surgery by the Study Coordinator. Surgical team, recruitment
staff, and scheduling staff will be masked to treatment assignment until day of surgery. All
tests and measurements should be obtained in accordance with the procedures specified in this
protocol. If it is not possible to perform a measurement or examination due to the individual
eye's specific ocular pathology, the reason for not performing the test or measurement should
be documented on the source documents.
The investigator may designate one or more surgeon sub-investigators at his/her investigative
site. A surgeon sub-investigator may evaluate subjects for the study and perform the Slit
Stent II lacrimal stent intubation. Surgeon sub-investigators will be listed on all
applicable investigator regulatory documents (including the delegation of responsibilities
log) and will complete all sponsor-required training for the study.
For the two post-op study visits, the Quality of Life (QOL) questionnaire (Glasgow Benefit
Inventory (GBI)- see Appendix A) and the Patient Tearing Questionnaire (Munk Scale and Lac-Q
questionnaire, see Appendix B) will be administered by an interviewer, and the interviewer
will record the subject's responses directly onto the corresponding questionnaire CRFs or
source documents and calculate the GBI score, Munk Score, and Lac-Q score.
Inclusion Criteria:
1. Willingness and ability to comply with schedule for follow-up visits and postoperative
evaluations.
2. Eligible for unilateral DCR surgery with stenting for treatment of epiphora secondary
to nasolacrimal duct obstruction.Ability to instill post-operative eye drop
3. Signed written, informed consent.
Exclusion Criteria:
1. Subjects under legal guardianship or who, in the investigator's opinion, lack the
mental capacity to provide written informed consent for study participation.
2. Subjects scheduled for bilateral DCR surgery
3. Subjects with known sensitivity to silicone
4. Subjects with a current condition that, in the investigator's opinion, would interfere
with the treatment.
5. Inability to use eye drops
6. Subjects with a known sensitivity to required study medications (e.g. antibiotic
drops) if an alternative medication is not available.
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