Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
NCT ID: NCT04412525
Last Updated: 2022-07-11
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
50 participants
INTERVENTIONAL
2020-06-05
2021-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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27 gauge needle vitrectomy surgery
ultra-small gauge
vitrectomy (27G gauge or larger needle)
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
larger than 27 gauge (23G or 25G) needle vitrectomy surgery
23-gauge and 25-gauge instruments are a little larger in size
vitrectomy (27G gauge or larger needle)
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
Interventions
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vitrectomy (27G gauge or larger needle)
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior vitrectomy surgery in the study eye (for the same eye)
* No prior inclusion in this trial
* Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
Exclusion Criteria
* Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction \>+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
* Patients with HIV
* Patients with history of drug abuse or alcoholism
* Patients participating in other drug or medical device clinical trials before screening for this trial
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Peter Stalmans, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S63610
Identifier Type: -
Identifier Source: org_study_id
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