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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Xen Gel Stent

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

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: New York University

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Ophthalmol Glaucoma. 2021 Nov-Dec;4(6):649.

Study record dates

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: Glaucoma surgery; Xen Gel Stent
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• 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