Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT05548959
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outflow Facility AIT vs Microshunt
Sponsor:
Wuerzburg University Hospital
Organization:
Study Overview
Official Title:
Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
Status:
COMPLETED
Status Verified Date:
2022-09
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:
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.
Detailed Description:
Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: