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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05126069

Acronym

LongGVT

Enrollment

242

Registered

2021-11-18

Start date

2018-08-21

Completion date

2020-08-28

Last updated

2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Filtering Surgery, Trabeculectomy

Keywords

Xen, Ab Interno Gelatin Microstent

Brief 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.

Interventions

DEVICEAb interno gelatin microstent

Ab interno gelatin microstent

PROCEDURETrabeculectomy

Trabeculectomy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients aged 30-90 * primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma * IOP of 18-40 on maximum tolerated medical therapy * received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.

Exclusion criteria

* Other forms of glaucoma * prior incisional glaucoma surgery * CPC * combined surgery (cataract, cornea, or retina) * prior corneal graft (PKP, DALK, DSAEK, DMEK)

Design outcomes

Primary

Measure	Time frame	Description
time to failure	up to 3 years	defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling)

Secondary

Measure	Time frame	Description
included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations	up to 3 years	Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026