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

National Taiwan University

Status: Unknown

Conditions: Vitrectomy; Wound Complication; High Myopia

Treatments: Device: 25G; Device: 27G

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04360603

201907025RINB

Details and patient eligibility

About

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

Enrollment: 108 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Highly myopic patients (axial length 26~31mm)
2. Diagnosed with vitreoretinal pathology that require vitrectomy
3. Never received vitrectomy before

Exclusion criteria

1. Surgical planning including scleral buckling during operation
2. Surgical planning including combined phacoemulsification
3. Surgical planning including the use of silicone oil and/or perfluorocarbon liquid
4. Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy
5. Previous vitrectomy
6. Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration
7. Medical history with known connective tissue disease(s)
8. Age younger than 20 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

27 gauge system

Experimental group

Description:

study group, using 27G vitrectomy system

Treatment:

Device: 27G

25 gauge system

Active Comparator group

Description:

control group, using 25G vitrectomy system

Treatment:

Device: 25G