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NCT04406467 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04406467
Other study ID # IRB00201210
Secondary ID 133133
Status Completed
Phase
First received
Last updated
Start date November 19, 2017
Est. completion date August 26, 2020

Study information
Verified date August 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date August 26, 2020
Est. primary completion date August 26, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Require surgery for uncontrolled glaucoma Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Johns Hopkins Univeristy Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University New York University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary re-intervention rate This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation 3 months
Secondary Change in intraocular pressure will be assessed as a % change in intraocular pressure 1 day, 1 week, 1 month and 3 months
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