NCT05126069

Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis

Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 242 (actual)
• Sponsor: Prism Eye Institute · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.

Detailed description

This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.

Conditions

• Filtering Surgery
• Trabeculectomy

Interventions

Type	Name	Description
DEVICE	Ab interno gelatin microstent	Ab interno gelatin microstent
PROCEDURE	Trabeculectomy	Trabeculectomy

Timeline

• Start date: 2018-08-21
• Primary completion: 2019-05-01
• Completion: 2020-08-28
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study