High Myopia, Vitrectomy, Wound Complication
Conditions
Keywords
vitrectomy, high myopia, wound leakage
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
Interventions
DEVICE27G
using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
DEVICE25G
using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
Sponsors
Alcon Research
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative sclerotomy site wound leakage | immediately at the end of surgery | The incidence of intraoperative sclerotomy site wound leakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotony | post-operation day 1, 3, week 1, month 1, 3, 6 | intraoperative and postoperative complication |
| Incidence of postoperative sclerotomy site wound leakage | post-operation day 1, 3, week 1, month 1, 3, 6 | postoperative complication |
| Incidence of endophthalmitis | post-operation day 1, 3, week 1, month 1, 3, 6 | postoperative complication |
| Incidence of instrument bending | during operation | intraoperative complications |
| Incidence of subconjunctival hemorrhage | post-operation day 1, 3, week 1, month 1, 3, 6 | postoperative complication |
Other
| Measure | Time frame | Description |
|---|---|---|
| visual outcomes | post-operation month 1, 3, 6 | best-corrected visual acuity and visual acuity changes |
| Incidence of anatomical success | post-operation month 1, 3, 6 | anatomical success, such as restoration of normal foveal contour, reattachment of retina |
| total surgical time | during operation | total surgical time |
| total vitrectomy time | during operation | total vitrectomy time |
Countries
Taiwan
Contacts
Primary ContactTso-Ting Lai, MD
Backup ContactYi-Ting Hsieh, MD, PhD
Outcome results
None listed