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Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement

NCT04454138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2020-08-14

Study results available
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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.

Conditions

Interventions

DEVICE

XEN-45 gelatin microstent

Placement either in the subconjunctival space or supratenon's area

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Prism Eye Institute

    lead OTHER

Principal Investigators

  • Iqbal Ike Ahmed, MD · Prism Eye Institute

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-04-20
Completion
2020-04-20
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454138 on ClinicalTrials.gov