Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach

Johns Hopkins University137 enrolled

Overview

To measure surgical success of open vs closed conjunctiva with Xen implantation.

This retrospective, single-arm multicenter study included \>100 eyes (\>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C. Success rates will be determined based on need for re-intervention and intraocular pressure control.

Study Type

OBSERVATIONAL

Enrollment

137

Conditions

Glaucoma, Open-Angle

Interventions

Xen Gel StentDEVICE

Ab-interno or Ab-Externa Xen with closed or open conjunctiva.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Require surgery for uncontrolled glaucoma Exclusion Criteria: * None

Locations (1)

Johns Hopkins Univeristy

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

re-intervention rate

This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation

Time frame: 3 months

Secondary Outcomes

Change in intraocular pressure

will be assessed as a % change in intraocular pressure

Time frame: 1 day, 1 week, 1 month and 3 months

Data from ClinicalTrials.gov

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