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

NCT ID: NCT04360603

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2021-08-31

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

Conditions

Wound Complication; High Myopia; Vitrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

27 gauge system

study group, using 27G vitrectomy system

Group Type: EXPERIMENTAL

27G

Intervention Type: DEVICE

using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

25 gauge system

control group, using 25G vitrectomy system

Group Type: ACTIVE_COMPARATOR

25G

Intervention Type: DEVICE

using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Interventions

27G

using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Intervention Type: DEVICE

25G

using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chung-May Yang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Tso-Ting Lai, MD

Role: CONTACT

b91401005@ntu.edu.tw

0972651992

Yi-Ting Hsieh, MD, PhD

Role: CONTACT

ythyth@gmail.com

0972655018

Facility Contacts

Chung-May Yang

Role: primary

chungmay@ntu.edu.tw

分機:65187；GSM:51547

Other Identifiers

201907025RINB

Identifier Type: -

Identifier Source: org_study_id