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

NCT ID: NCT04406467

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-19

Study Completion Date

2020-08-26

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma, Open-Angle

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Xen Gel Stent

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Require surgery for uncontrolled glaucoma

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins Univeristy

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32200534 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33321200 (View on PubMed)

Other Identifiers

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133133

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00201210

Identifier Type: -

Identifier Source: org_study_id

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