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OpenTrials
Completed

NCT Number: NCT05126069

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

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

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Key information

Conditions

Filtering Surgery Trabeculectomy

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prism Eye Institute

Oakville, Ontario, L6H 0J8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ab interno gelatin microstent

Device

Ab interno gelatin microstent

trabeculectomy

Procedure

Trabeculectomy

Primary outcomes

  1. time to failure

    Time frame: 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 outcomes

  1. included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations

    Time frame: up to 3 years

    Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.

Sponsors and collaborators

Lead sponsor

Prism Eye Institute

Other

Registry information

Official study title

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

Acronym: LongGVT

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 18, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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