Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT04360603
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
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:
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: