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

NCT04360603 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-04-24

No results posted yet for this study

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

DEVICE

27G

using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

DEVICE

25G

using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chung-May Yang, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-02-28
Completion
2021-08-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360603 on ClinicalTrials.gov