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

NCT ID: NCT05126069

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-21

Study Completion Date

2020-08-28

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.

Conditions

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Filtering Surgery Trabeculectomy

Keywords

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Xen Ab Interno Gelatin Microstent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standalone Xen45

consecutive patients from June 2012 - July 2017 who received standalone Xen45®

Ab interno gelatin microstent

Intervention Type DEVICE

Ab interno gelatin microstent

Standalone Trabeculectomy

consecutive patients from June 2012 - July 2017 who received standalone trabeculectomy

Trabeculectomy

Intervention Type PROCEDURE

Trabeculectomy

Interventions

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Ab interno gelatin microstent

Ab interno gelatin microstent

Intervention Type DEVICE

Trabeculectomy

Trabeculectomy

Intervention Type PROCEDURE

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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prism Eye Institute

OTHER

Sponsor Role lead

Responsible Party

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Iqbal Ahmed

Chief Innovation Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prism Eye Institute

Oakville, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT

Related Links

Other Identifiers

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2018-10376

Identifier Type: -

Identifier Source: org_study_id