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

High Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04360603
• Other study ID #: 201907025RINB
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: National Taiwan University Hospital
• Contact: Tso-Ting Lai, MD
• Phone: 0972651992
• Email: b91401005[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: August 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Myopia
• Myopia
• Vitrectomy
• Wound Complication

Intervention

Device:
• 27G
using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
• 25G
using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Alcon Research

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total vitrectomy time	total vitrectomy time	during operation
Other	total surgical time	total surgical time	during operation
Other	visual outcomes	best-corrected visual acuity and visual acuity changes	post-operation month 1, 3, 6
Other	Incidence of anatomical success	anatomical success, such as restoration of normal foveal contour, reattachment of retina	post-operation month 1, 3, 6
Primary	Incidence of intraoperative sclerotomy site wound leakage	The incidence of intraoperative sclerotomy site wound leakage	immediately at the end of surgery
Secondary	Incidence of postoperative sclerotomy site wound leakage	postoperative complication	post-operation day 1, 3, week 1, month 1, 3, 6
Secondary	Incidence of hypotony	intraoperative and postoperative complication	post-operation day 1, 3, week 1, month 1, 3, 6
Secondary	Incidence of endophthalmitis	postoperative complication	post-operation day 1, 3, week 1, month 1, 3, 6
Secondary	Incidence of instrument bending	intraoperative complications	during operation
Secondary	Incidence of subconjunctival hemorrhage	postoperative complication	post-operation day 1, 3, week 1, month 1, 3, 6