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

Completed

• Conditions: Glaucoma, Open-Angle

• Registration Number: NCT04406467
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2017-11-19
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-24
• Study First Posted: 2020-05-28
• Status Verified: 2020-08
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Require surgery for uncontrolled glaucoma

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
re-intervention rate	3 months	This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Univeristy; 🇺🇸 Baltimore, Maryland, United States