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

Primary Purpose

Wound Complication, High Myopia, Vitrectomy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
27G
25G
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Complication focused on measuring vitrectomy, high myopia, wound leakage

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

27 gauge system

25 gauge system

Arm Description

study group, using 27G vitrectomy system

control group, using 25G vitrectomy system

Outcomes

Primary Outcome Measures

Incidence of intraoperative sclerotomy site wound leakage
The incidence of intraoperative sclerotomy site wound leakage

Secondary Outcome Measures

Incidence of postoperative sclerotomy site wound leakage
postoperative complication
Incidence of hypotony
intraoperative and postoperative complication
Incidence of endophthalmitis
postoperative complication
Incidence of instrument bending
intraoperative complications
Incidence of subconjunctival hemorrhage
postoperative complication

Full Information

First Posted
April 19, 2020
Last Updated
April 22, 2020
Sponsor
National Taiwan University Hospital
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04360603
Brief Title
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
Official Title
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Complication, High Myopia, Vitrectomy
Keywords
vitrectomy, high myopia, wound leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
27 gauge system
Arm Type
Experimental
Arm Description
study group, using 27G vitrectomy system
Arm Title
25 gauge system
Arm Type
Active Comparator
Arm Description
control group, using 25G vitrectomy system
Intervention Type
Device
Intervention Name(s)
27G
Intervention Description
using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
Intervention Type
Device
Intervention Name(s)
25G
Intervention Description
using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
Primary Outcome Measure Information:
Title
Incidence of intraoperative sclerotomy site wound leakage
Description
The incidence of intraoperative sclerotomy site wound leakage
Time Frame
immediately at the end of surgery
Secondary Outcome Measure Information:
Title
Incidence of postoperative sclerotomy site wound leakage
Description
postoperative complication
Time Frame
post-operation day 1, 3, week 1, month 1, 3, 6
Title
Incidence of hypotony
Description
intraoperative and postoperative complication
Time Frame
post-operation day 1, 3, week 1, month 1, 3, 6
Title
Incidence of endophthalmitis
Description
postoperative complication
Time Frame
post-operation day 1, 3, week 1, month 1, 3, 6
Title
Incidence of instrument bending
Description
intraoperative complications
Time Frame
during operation
Title
Incidence of subconjunctival hemorrhage
Description
postoperative complication
Time Frame
post-operation day 1, 3, week 1, month 1, 3, 6
Other Pre-specified Outcome Measures:
Title
total vitrectomy time
Description
total vitrectomy time
Time Frame
during operation
Title
total surgical time
Description
total surgical time
Time Frame
during operation
Title
visual outcomes
Description
best-corrected visual acuity and visual acuity changes
Time Frame
post-operation month 1, 3, 6
Title
Incidence of anatomical success
Description
anatomical success, such as restoration of normal foveal contour, reattachment of retina
Time Frame
post-operation month 1, 3, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Highly myopic patients (axial length 26~31mm) Diagnosed with vitreoretinal pathology that require vitrectomy Never received vitrectomy before Exclusion criteria: Surgical planning including scleral buckling during operation Surgical planning including combined phacoemulsification Surgical planning including the use of silicone oil and/or perfluorocarbon liquid Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy Previous vitrectomy Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration Medical history with known connective tissue disease(s) Age younger than 20 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tso-Ting Lai, MD
Phone
0972651992
Email
b91401005@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ting Hsieh, MD, PhD
Phone
0972655018
Email
ythyth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-May Yang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-May Yang
Phone
分機:65187;GSM:51547
Email
chungmay@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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