Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-03 @ 2:49 AM
Study NCT ID:
NCT03677869
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Pneumatic Vitreolysis on Macular Hole
Sponsor:
Jaeb Center for Health Research
Organization:
Study Overview
Official Title:
Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
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:
Protocol AH
Brief Summary:
Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.
Detailed Description:
The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10EY014231 | NIH | None | https://reporter.nih.gov/quic… | View |