Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
NCT ID: NCT04859556
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2018-05-01
2020-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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10k 25G cutter
New cutter, with a 10,000 cut per minute blade
Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
5k 25G cutter
Traditional cutter, with a 5,000 cut per minute blade
Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
Interventions
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Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
The University of Hong Kong
OTHER
Responsible Party
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Locations
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University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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10K
Identifier Type: -
Identifier Source: org_study_id
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