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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05126069
Other study ID # 2018-10376
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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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