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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared
Purpose:
This study aims to compare the performance of the Alcon 25+® UltraVit® 5000 cpm vitrectomy probe versus the 25+® Ultravit 10,000 cpm® beveled tip, dual drive vitrectomy probe. The safety profile and efficiency were compared.
Method:
Prospective, randomised study. Consecutive patients from January 2019 to August 2019 requiring vitrectomy for retinal detachment, epiretinal membrane, vitreous haemorrhage, and macula hole were randomized into either the 10K or 5K vitrectomy group. Both groups underwent vitrectomy using the proportional vacuum mode with the cut rate set at the fastest rate. Patients with previous vitrectomy, other ocular diseases (glaucoma, corneal disease, or significant corneal opacities), or trauma were excluded from the study. The primary endpoint was vitrectomy time, while secondary endpoints included posterior vitreous detachment time, intraoperative complications, and number of instruments used. The preoperative, postoperative 1 month and 3 month best corrected visual acuity (BCVA), and complications were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10k 25G cutter | Experimental | New cutter, with a 10,000 cut per minute blade |
|
| 5k 25G cutter | Active Comparator | Traditional cutter, with a 5,000 cut per minute blade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter | Device | a proprietary Vitrector from Alcon for the use on the Constellation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitrectomy time | The time needed to remove all vitreous | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and complications | Associated Intraoperative and post operative complications | up to 6 months |
| Number of instruments used | The total number of additional instruments used (scissors, forceps, etc) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong | Hong Kong | Hong Kong |
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Patients and Care provider are not able to differentiate the two different cutters since the port size are the exact same for both.
| Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter | Device | a proprietary Vitrector from Alcon for the use on the Constellation system |
|
| 1 Day |
| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| D012167 | Retinal Perforations |
| D019773 | Epiretinal Membrane |
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |
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