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

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Johns Hopkins University

Status

Completed

Conditions

Glaucoma, Open-Angle

Treatments

Device: Xen Gel Stent

Study type

Observational

Funder types

Other

Identifiers

NCT04406467
133133 (Other Grant/Funding Number)
IRB00201210

Details and patient eligibility

About

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

Full 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.

Enrollment

137 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Require surgery for uncontrolled glaucoma

Exclusion criteria

  • None

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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