Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-02 @ 9:04 AM
Study NCT ID:
NCT04406467
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Success rates will be determined based on need for re-intervention and intraocular pressure control.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 133133 | OTHER_GRANT | Allergan Inc. | View |