EpiphoraSLINDONCT03705000
SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
A study testing Slit Stent II and BIKA for DCR in people with Epiphora and Dacryocystorhinostomy, run by Thomas Gardner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Epiphora, Dacryocystorhinostomy
- What is being tested?
- Slit Stent II and BIKA for DCR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 11 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kellogg Eye Center, 1000 Wall Street
Ann Arbor, Michigan, 48105
About this study
Official title: 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.
Read the detailed description
This is a single center study that will be conducted at the University of Michigan (Ann Arbor, Michigan). Fifty (50) 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 1:1 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.
- Conditions
- Epiphora, Dacryocystorhinostomy
- Being tested
- Slit Stent II, BIKA for DCR
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit Stent IIDevice
Also called Lacrimal Stent
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.
BIKA for DCRDevice
Also called stent
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: BIKA for DCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Surgery to final exit visit (Month 4-7)
Secondary outcomes (2)
Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)
The effectiveness parameter evaluated will be the mean composite score for the GBI administered post-treatment at the 1-4 month post-operative follow-up visit. Scores can range from -100 to 100 where -100 represents decline in symptoms or function and 100 represents greatest improvement.
Measured: 1-4 month post-operative follow-up visit
Lac-Q Score
The Lac-Q questionnaire, published in 2011, is a patient symptom questionnaire developed for lacrimal drainage surgery.1-2 The questionnaire contains two scores, one is specific for eye-symptoms (14 points for each eye), and the other assesses the social impact of symptoms (5 points) . The scores are combined for a single Lac-Q score, whose lowest possible score can be 0 and highest score is 33, where 0 represents no problems related to watery eyes and 33 represents the most possible symptoms and social challenge from them.
Measured: 1-4 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start16 Oct 2020
- Primary completion11 May 2022
- Study completion11 May 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpiphoraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Gardner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Gardner, University of Michigan
- Investigators
- Thomas Gardner, MD, MS, Principal investigator, University of Michigan Kellogg Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705000
- Sponsor's protocol ID
- HUM00114919
- Acronym
- SLINDO
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2018
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT03705000
- Acronym / sponsor ID
- SLINDO / HUM00114919
- Conditions
- Epiphora, Dacryocystorhinostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Thomas GardnerUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center study that will be conducted at the University of Michigan (Ann Arbor, Michigan). Fifty (50) 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 1:1 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slit Stent II | Experimental | Device: Slit Stent IIThe 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. |
| BIKA for DCR | Active comparator | Device: BIKA for DCRThe BIKA for DCR is a sterile, single-use device, and is an FDA cleared device. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slit Stent IIAlso: Lacrimal StentThe 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 | Slit Stent II |
| BIKA for DCRAlso: stentThe 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 | Device | BIKA for DCR |
Primary outcome
Safety, as Measured by Number of Subjects With at Least One Adverse Event
Time frame: Surgery to final exit visit (Month 4-7)
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).
2 secondary outcomes
Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)
Time frame: 1-4 month post-operative follow-up visit
Lac-Q Score
Time frame: 1-4 months post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gardner, MD, MS principal investigator
University of Michigan Kellogg Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slit Stent II and BIKA for DCR in people with Epiphora and Dacryocystorhinostomy, run by Thomas Gardner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as Measured by Number of Subjects With at Least One Adverse Event (time frame: Surgery to final exit visit (Month 4-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.