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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 27 gauge system | Experimental | study group, using 27G vitrectomy system |
|
| 25 gauge system | Active Comparator | control group, using 25G vitrectomy system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 27G | Device | using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative sclerotomy site wound leakage | The incidence of intraoperative sclerotomy site wound leakage | immediately at the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative sclerotomy site wound leakage | postoperative complication | post-operation day 1, 3, week 1, month 1, 3, 6 |
| Incidence of hypotony | intraoperative and postoperative complication |
| Measure | Description | Time Frame |
|---|---|---|
| total vitrectomy time | total vitrectomy time | during operation |
| total surgical time | total surgical time | during operation |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tso-Ting Lai, MD | Contact | 0972651992 | b91401005@ntu.edu.tw | |
| Yi-Ting Hsieh, MD, PhD | Contact | 0972655018 | ythyth@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chung-May Yang, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| 25G | Device | using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy |
|
| post-operation day 1, 3, week 1, month 1, 3, 6 |
| Incidence of endophthalmitis | postoperative complication | post-operation day 1, 3, week 1, month 1, 3, 6 |
| Incidence of instrument bending | intraoperative complications | during operation |
| Incidence of subconjunctival hemorrhage | postoperative complication | post-operation day 1, 3, week 1, month 1, 3, 6 |
| visual outcomes | best-corrected visual acuity and visual acuity changes | post-operation month 1, 3, 6 |
| Incidence of anatomical success | anatomical success, such as restoration of normal foveal contour, reattachment of retina | post-operation month 1, 3, 6 |