Skip to main content
OpenTrials
Completed

NCT Number: NCT04406467

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Univeristy

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Require surgery for uncontrolled glaucoma

Exclusion criteria

  • None

Treatment and study plan

Xen Gel Stent

Device

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

Primary outcomes

  1. re-intervention rate

    Time frame: 3 months

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

Secondary outcomes

  1. Change in intraocular pressure

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

    will be assessed as a % change in intraocular pressure

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • New York University

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.