Glaucoma, Open-Angle
Conditions
Keywords
Glaucoma surgery, Xen Gel Stent
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.
Interventions
DEVICEXen Gel Stent
Ab-interno or Ab-Externa Xen with closed or open conjunctiva.
Sponsors
New York University
Johns Hopkins University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Require surgery for uncontrolled glaucoma
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| re-intervention rate | 3 months | This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in intraocular pressure | 1 day, 1 week, 1 month and 3 months | will be assessed as a % change in intraocular pressure |
Countries
United States
Outcome results
None listed