Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis
LongGVT
Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis
1 other identifier
observational
242
1 country
1
Brief Summary
To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedFirst Submitted
Initial submission to the registry
November 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedNovember 18, 2021
November 1, 2021
8 months
November 5, 2021
November 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations
up to 3 years
Study Arms (2)
Standalone Xen45
consecutive patients from June 2012 - July 2017 who received standalone Xen45®
Standalone Trabeculectomy
consecutive patients from June 2012 - July 2017 who received standalone trabeculectomy
Interventions
Eligibility Criteria
Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a trabeculectomy with MMC
You may qualify if:
- 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.
You may not qualify if:
- Other forms of glaucoma
- prior incisional glaucoma surgery
- CPC
- combined surgery (cataract, cornea, or retina)
- prior corneal graft (PKP, DALK, DSAEK, DMEK)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prism Eye Institute
Oakville, Ontario, L6H 0J8, Canada
Related 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.
RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Innovation Officer
Study Record Dates
First Submitted
November 5, 2021
First Posted
November 18, 2021
Study Start
August 21, 2018
Primary Completion
May 1, 2019
Study Completion
August 28, 2020
Last Updated
November 18, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share