CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
XEN-45 gelatin microstentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04454138
NCT04454138N/ACompleted
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Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement

Prism Eye Institute·observational·Posted Jul 1, 2020·Updated Aug 14, 2020

In Brief

An observational study evaluating XEN-45 gelatin microstent for Glaucoma. Completed, enrolled 142 participants across 1 site.

Detailed Summary

The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesCanada
CollaboratorsAllergan

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 1, 2020
Enrollment StartJun 25, 2019
Primary CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.0 years ago

Interventions

XEN-45 gelatin microstentdevice

Placement either in the subconjunctival space or supratenon's area