Retrospective Review of Xen Gel Stent Implantation With O... | NCT04406467

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

NCT04406467

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

May 25, 2023Actual

Enrollment

137Actual

Phase

Not provided

Conditions

Glaucoma, Open-Angle

Interventions

Xen Gel Stent

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
133133	Other Grant/Funding Number	Allergan Inc.

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2017Actual

Primary Completion Date

Aug 26, 2020Actual

Completion Date

Aug 26, 2020Actual

First Submitted Date

May 24, 2020

First Submission Date that Met QC Criteria

May 24, 2020

First Posted Date

May 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2023

Last Update Posted Date

May 25, 2023Actual

Name	Class
New York University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xen Gel Stent	Device	Ab-interno or Ab-Externa Xen with closed or open conjunctiva.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Require surgery for uncontrolled glaucoma

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Univeristy		Baltimore	Maryland	21287	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32200534	Background	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.
33321200	Derived	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases