The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
1 other identifier
interventional
108
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedApril 24, 2020
April 1, 2020
10 months
April 19, 2020
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of intraoperative sclerotomy site wound leakage
The incidence of intraoperative sclerotomy site wound leakage
immediately at the end of surgery
Secondary Outcomes (5)
Incidence of postoperative sclerotomy site wound leakage
post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of hypotony
post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of endophthalmitis
post-operation day 1, 3, week 1, month 1, 3, 6
Incidence of instrument bending
during operation
Incidence of subconjunctival hemorrhage
post-operation day 1, 3, week 1, month 1, 3, 6
Other Outcomes (4)
total vitrectomy time
during operation
total surgical time
during operation
visual outcomes
post-operation month 1, 3, 6
- +1 more other outcomes
Study Arms (2)
27 gauge system
EXPERIMENTALstudy group, using 27G vitrectomy system
25 gauge system
ACTIVE COMPARATORcontrol group, using 25G vitrectomy system
Interventions
Eligibility Criteria
You may qualify if:
- Highly myopic patients (axial length 26\~31mm)
- Diagnosed with vitreoretinal pathology that require vitrectomy
- Never received vitrectomy before
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Alcon Researchcollaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-May Yang, MD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2020
First Posted
April 24, 2020
Study Start
April 1, 2020
Primary Completion
February 1, 2021
Study Completion
August 1, 2021
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share