Trials / Completed
CompletedNCT04406467
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 137 (actual)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xen Gel Stent | Ab-interno or Ab-Externa Xen with closed or open conjunctiva. |
Timeline
- Start date
- 2017-11-19
- Primary completion
- 2020-08-26
- Completion
- 2020-08-26
- First posted
- 2020-05-28
- Last updated
- 2023-05-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04406467. Inclusion in this directory is not an endorsement.