NCT04406467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

May 25, 2023

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

May 24, 2020

Last Update Submit

May 24, 2023

Conditions

Glaucoma, Open-Angle

Keywords

Glaucoma surgeryXen Gel Stent

Outcome Measures

Primary Outcomes (1)

  • re-intervention rate

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

    3 months

Secondary Outcomes (1)

  • Change in intraocular pressure

    1 day, 1 week, 1 month and 3 months

Interventions

Xen Gel StentDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Require surgery for uncontrolled glaucoma

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Univeristy

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.

    PMID: 32200534BACKGROUND

  • Do A, McGlumphy E, Shukla A, Dangda S, Schuman JS, Boland MV, Yohannan J, Panarelli JF, Craven ER. Comparison of Clinical Outcomes with Open Versus Closed Conjunctiva Implantation of the XEN45 Gel Stent. Ophthalmol Glaucoma. 2021 Jul-Aug;4(4):343-349. doi: 10.1016/j.ogla.2020.12.003. Epub 2020 Dec 13.

    PMID: 33321200DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 28, 2020

Study Start

November 19, 2017

Primary Completion

August 26, 2020

Study Completion

August 26, 2020

Last Updated

May 25, 2023

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

De-identified internal use data.

Locations

US(1)