Macular Disease
Conditions
Keywords
Macular disease, Vitrectomy
Brief summary
The purpose of this study is to compare the efficiency and safety of ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)).
Detailed description
During the last few decades, there have been dramatic changes in vitreoretinal surgery field with improvements in the performance of surgical retina equipment. As the innovation trend has been moving toward the smaller instrument calibers, the 27-gauge vitrectomy system has been developed. However, the vitrectomy system with the smaller calibers have limitations such as reduced instrument rigidity, limited availability of instrumentation, and decreased flow rate. To overcome these limitations, active developments have been ongoing to increase vitreous cutting speed, enlargement of the cutting port size, and enlargement of inner shaft to enable higher flow rates. Especially, the ultrahigh-speed cutter with improved cutting speed has the advantage of enabling safer vitrectomy because the faster cutting speed reduces retinal movement and minimizes the risk of iatrogenic retinal breaks. However, ultrahigh-speed cutting has a limitation in that it can reduce the flow rate through the vitreous cutter as it affects the duty cycle (percentage of time the cutter port is open relative to the complete cutting cycle). Therefore, the duty cycle of ultrahigh-speed cutter has also been improved so as not to delay the time for vitrectomy. The investigators would like to evaluate the efficiency and safety of vitrectomy using a recently released ultra high-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and a standard cut rate 27-gauge system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) by comparing the duration of vitrectomy and the rate of complications.
Interventions
DEVICEUltrahigh-speed cut rate 27-gauge system
The ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))
DEVICEStandard cut rate 27-gauge system
The current standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))
Sponsors
Alcon Research
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All consecutive eyes requiring macular surgery (i.e. epiretinal membrane, vitreomacular traction etc.) that underwent 27-gauge vitrectomy at Seoul National University Bundang Hospital (SNUBH) from September 2022 to August 2023. Patients will be randomized to receive 27-gauge vitrectomy with 20,000 cpm probes (20K group) or 27-gauge vitrectomy with 10,000 cpm probes (standard group).
Exclusion criteria
1. Previously vitrectomized eye 2. Trauma cases 3. Proliferative diabetic retinopathy with fibrovascular membranes 4. Retinal detachment with proliferative vitreoretinopathy 5. Macular hole 6. Endophthalmitis 7. Inability to consent for procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of core vitrectomy | During the vitrectomy | Time to completion of core vitrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | During the vitrectomy | i.e. iatrogenic retinal breaks, intraocular bleeding, retinal detachment, etc. |
| Postoperative complications | Postoperative period within 4 months after the vitrectomy | i.e. intraocular bleeding, retinal detachment, etc. |
| Efficiency of peripheral vitrectomy | During the vitrectomy | Time to completion of peripheral vitrectomy |
| Efficiency of surgery | During the surgery | Time to completion of the surgery |
Countries
South Korea
Contacts
Primary ContactKyu Hyung Park, M.D., Ph.D.
Backup ContactSe Joon Woo, M.D.
Outcome results
None listed