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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 2020

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.

Interventions

  • Device: Xen Gel Stent
    • Ab-interno or Ab-Externa Xen with closed or open conjunctiva.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Require surgery for uncontrolled glaucoma

Exclusion Criteria

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • New York University
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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