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

Not Applicable

• Conditions: Wound Complication; Vitrectomy; High Myopia
• Interventions: Device: 27G; Device: 25G

• Registration Number: NCT04360603
• Lead Sponsor: National Taiwan University Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2021-02
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
27 gauge system	27G	study group, using 27G vitrectomy system
25 gauge system	25G	control group, using 25G vitrectomy system

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative sclerotomy site wound leakage	immediately at the end of surgery	The incidence of intraoperative sclerotomy site wound leakage

Secondary Outcome Measures

Name	Time	Method
Incidence of hypotony	post-operation day 1, 3, week 1, month 1, 3, 6	intraoperative and postoperative complication
Incidence of endophthalmitis	post-operation day 1, 3, week 1, month 1, 3, 6	postoperative complication
Incidence of postoperative sclerotomy site wound leakage	post-operation day 1, 3, week 1, month 1, 3, 6	postoperative complication
Incidence of instrument bending	during operation	intraoperative complications
Incidence of subconjunctival hemorrhage	post-operation day 1, 3, week 1, month 1, 3, 6	postoperative complication

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan