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New stent aims to dry up tears after eye surgery

NCT ID NCT03705000

Symptom relief Sponsor: Thomas Gardner Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a redesigned lacrimal stent, called the Slit Stent II, for people with severe tearing (epiphora) caused by a blocked tear duct. The stent has slits to allow tears to drain while it is still in place after DCR surgery. The trial planned to enroll 5 people to check safety and symptom relief, but it was terminated early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Slit Stent II lacrimal stent (a modified medical device)
What this could lead to
If it works, this could offer a way to relieve severe tearing sooner after DCR surgery without compromising long-term results.
What could go wrong
This was a very small, early trial (only 5 participants planned) that was terminated, so results are limited. The device is a modification of an existing stent, and its safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Oct 2020

Finished

May 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

excessive tearing familial congenital nasolacrimal duct obstruction lacrimal apparatus disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dacryocystorhinostomy Epiphora

Contacts and locations

Locations

  • Kellogg Eye Center, 1000 Wall Street

    Ann Arbor, Michigan, 48105, United States

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