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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04360603
• Collaborator: Alcon Research (Industry)
• Enrollment: 108
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wound Complication; High Myopia; Vitrectomy	Device: 27G; Device: 25G	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
• Anticipated Study Start Date: Apr 1, 2020
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 27 gauge system study group, using 27G vitrectomy system	Device: 27G; using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
Active Comparator: 25 gauge system control group, using 25G vitrectomy system	Device: 25G; using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Outcome Measures

Primary Outcome Measures

1. Incidence of intraoperative sclerotomy site wound leakage [immediately at the end of surgery]

   The incidence of intraoperative sclerotomy site wound leakage

Secondary Outcome Measures

1. Incidence of postoperative sclerotomy site wound leakage [post-operation day 1, 3, week 1, month 1, 3, 6]

   postoperative complication

2. Incidence of hypotony [post-operation day 1, 3, week 1, month 1, 3, 6]

   intraoperative and postoperative complication

3. Incidence of endophthalmitis [post-operation day 1, 3, week 1, month 1, 3, 6]

   postoperative complication

4. Incidence of instrument bending [during operation]

   intraoperative complications

5. Incidence of subconjunctival hemorrhage [post-operation day 1, 3, week 1, month 1, 3, 6]

   postoperative complication

Other Outcome Measures

1. total vitrectomy time [during operation]

   total vitrectomy time

2. total surgical time [during operation]

   total surgical time

3. visual outcomes [post-operation month 1, 3, 6]

   best-corrected visual acuity and visual acuity changes

4. Incidence of anatomical success [post-operation month 1, 3, 6]

   anatomical success, such as restoration of normal foveal contour, reattachment of retina

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital
• Alcon Research

Investigators

• Principal Investigator: Chung-May Yang, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04360603
• Other Study ID Numbers: 201907025RINB
• First Posted: Apr 24, 2020
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by National Taiwan University Hospital: vitrectomy; high myopia; wound leakage
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Apr 24, 2020