NCT04360603

The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Wound Complication
• High Myopia
• Vitrectomy

Interventions

Type	Name	Description
DEVICE	27G	using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
DEVICE	25G	using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-02-01
• Completion: 2021-08-01
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study