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Procedure

Slit Stent II for Watery Eyes (SLINDO Trial)

N/A
Waitlist Available
Led By Thomas Gardner, MD, MS
Research Sponsored by Thomas Gardner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery to final exit visit (month 4-7)
Awards & highlights

SLINDO Trial Summary

This trial aims to test a newly designed lacrimal stent that allows tears to drain, providing symptomatic relief more quickly after DCR surgery.

Eligible Conditions
  • Watery Eyes
  • Dacryocystorhinostomy

SLINDO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery to final exit visit (month 4-7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery to final exit visit (month 4-7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety, as measured by number of subjects with at least one Adverse Event
Secondary outcome measures
Glasgow Benefit Inventory (GBI) Questionnaire (Quality of Life)
Lac-Q score

SLINDO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Slit Stent IIExperimental Treatment1 Intervention
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.
Group II: BIKA for DCRActive Control1 Intervention
The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device.

Find a Location

Who is running the clinical trial?

Thomas GardnerLead Sponsor
2 Previous Clinical Trials
63 Total Patients Enrolled
Shannon JosephLead Sponsor
Thomas Gardner, MD, MSPrincipal InvestigatorUniversity of Michigan Kellogg Eye Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to take part in this research trial?

"This research endeavour is actively seeking participants, as indicated on the clinicaltrials.gov website. The trial was initially posted in October 2020 and has been amended most recently July 5th 2022."

Answered by AI

How many people have been admitted to participate in this clinical experiment?

"Indeed, according to clinicaltrials.gov, this medical study is currently in the patient recruitment phase. Initially posted on October 1st 2020 and most recently updated on July 5th 2022, it calls for 15 individuals at a single site."

Answered by AI
~22 spots leftby Dec 2026