Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 2:19 PM
Study NCT ID:
NCT03647267
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Sponsor:
Jaeb Center for Health Research
Organization:
Study Overview
Official Title:
Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction
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:
AG
Brief Summary:
Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.
Detailed Description:
Investigational Device: 0.3-mL intraocular gas (C3F8) injection
Objectives
Primary
1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.
Secondary
2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.
Study Design: Multi-center, randomized clinical trial
Objectives
Primary
1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.
Secondary
2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.
Study Design: Multi-center, randomized clinical trial
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 |
| U10EY023207 | NIH | None | https://reporter.nih.gov/quic… | View |