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

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

Detailed Description
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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.

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

Conditions
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Filtering Surgery, Trabeculectomy

Intervention / Treatment
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* Device: Ab interno gelatin microstent
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standalone Xen45<br>consecutive patients from June 2012 - July 2017 who received standalone Xen45® | Device: Ab interno gelatin microstent<br>* Ab interno gelatin microstent<br>|
| Standalone Trabeculectomy<br>consecutive patients from June 2012 - July 2017 who received standalone trabeculectomy | Procedure: Trabeculectomy<br>* Trabeculectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xen, Ab Interno Gelatin Microstent