Clinical trial NCT04360603: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Complication
High Myopia
Vitrectomy
Keywords: vitrectomy
high myopia
wound leakage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-04-24
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of intraoperative sclerotomy site wound leakage
timeFrame: immediately at the end of surgery
Secondary outcomes:
measure: Incidence of postoperative sclerotomy site wound leakage
timeFrame: post-operation day 1, 3, week 1, month 1, 3, 6
measure: Incidence of hypotony
timeFrame: post-operation day 1, 3, week 1, month 1, 3, 6
measure: Incidence of endophthalmitis
timeFrame: post-operation day 1, 3, week 1, month 1, 3, 6
measure: Incidence of instrument bending
timeFrame: during operation
measure: Incidence of subconjunctival hemorrhage
timeFrame: post-operation day 1, 3, week 1, month 1, 3, 6
Other outcomes:
measure: total vitrectomy time
timeFrame: during operation
measure: total surgical time
timeFrame: during operation
measure: visual outcomes
timeFrame: post-operation month 1, 3, 6
measure: Incidence of anatomical success
timeFrame: post-operation month 1, 3, 6
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chung-May Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: