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

Prism Eye Institute242 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

242

Conditions

Filtering Surgery Trabeculectomy

Interventions

Ab interno gelatin microstentDEVICE

Ab interno gelatin microstent

TrabeculectomyPROCEDURE

Trabeculectomy

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Prism Eye Institute

Oakville, Ontario, Canada

Outcomes

Primary Outcomes

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)

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

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

Time frame: up to 3 years

Data from ClinicalTrials.gov

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