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

Trabeculectomy Clinical Trial

— LongGVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126069
• Other study ID #: 2018-10376
• Status: Completed
• Start date: August 21, 2018
• Est. completion date: August 28, 2020

Study information

• Verified date: November 2021
• Source: Prism Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 28, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Filtering Surgery
• Trabeculectomy

Intervention

Device:
• Ab interno gelatin microstent
Ab interno gelatin microstent

Procedure:
• Trabeculectomy
Trabeculectomy

Locations

Country	Name	City	State
Canada	Prism Eye Institute	Oakville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Prism Eye Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

J Liu, M Schlenker, I Ahmed. Long-Term Efficacy & Safety of Standalone Ab Interno Gelatin Microstent Implantation with MMC Vs. Trabeculectomy with MMC: 3 Year Follow-up. ASCRS Conference 2021.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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