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

May 24, 2023 updated by: Johns Hopkins University
To measure surgical success of open vs closed conjunctiva with Xen implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the two institutions with elevated IOP and required surgery to lower IOP.

Description

Inclusion Criteria:

  • Require surgery for uncontrolled glaucoma

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intraocular pressure
Time Frame: 1 day, 1 week, 1 month and 3 months
will be assessed as a % change in intraocular pressure
1 day, 1 week, 1 month and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2017

Primary Completion (Actual)

August 26, 2020

Study Completion (Actual)

August 26, 2020

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00201210
  • 133133 (Other Grant/Funding Number: Allergan Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified internal use data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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