Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
NCT ID: NCT02477605
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2015-07-16
2016-08-31
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 pak
CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
CONSTELLATION® 27-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.
Vitrectomy surgery
Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
23-gauge pak
CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
CONSTELLATION® 23-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.
Vitrectomy surgery
Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
Interventions
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CONSTELLATION® 27-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.
CONSTELLATION® 23-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.
Vitrectomy surgery
Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
Eligibility Criteria
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Inclusion Criteria
* Requires vitrectomy in at least one eye;
Exclusion Criteria
* Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
* Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
* Pregnant or planning to become pregnant during the course of the trial;
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Manager, Surgical, GCRA
Role: STUDY_DIRECTOR
Alcon, A Novartis Division
Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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VRH172-P001
Identifier Type: -
Identifier Source: org_study_id
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