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
44 participants
OBSERVATIONAL
2006-01-31
2007-09-30
Brief Summary
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Detailed Description
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Purpose: The goal of the study is to determine the most efficient surgical settings for each sleeve diameter and determine statistically the surgical parameters which optimize the use of each phacoemulsification sleeve.
Design: The study is designed to allow for scientific evaluation and publication of efficiency parameters using phacoemulsification sleeves of 2.2, 2.8, and 3.0 mm. The proposed study is a prospective nonrandomized clinical investigation of 50 patients per sleeve group.
Methods: Data gathered at the time of surgery will include standard surgical parameters including: Total surgical time, total phacoemulsification/torsional time/power, total volume of infusion fluid, aspiration level, and vacuum level. Post-operative data will include: Post-op day one and week three corneal clarity (clear, would edema, central edema), anterior chamber cell seen in a 2mm 16x magnified slit-lamp biomicroscopic view focused in the aqueous humor (Grade 0 = 0 cells, 1 = up to 10 cells, 2 = 10 to 20 cells, 3 = 20 to 30 cells, 4 = too numerous to count), and uncorrected and/or best corrected visual acuity.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Phacoemulsification Sleeve 2.2mm
Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeve surgery
Group 2.2 mm surgery setting
Phacoemulsification Sleeve 2.8mm
Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeves surgery
Group 2.8 mm surgery setting
Phacoemulsification Sleeve 3.0mm
Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeves
Group 3.0 mm surgery setting
Interventions
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Phacoemulsification Sleeve surgery
Group 2.2 mm surgery setting
Phacoemulsification Sleeves surgery
Group 2.8 mm surgery setting
Phacoemulsification Sleeves
Group 3.0 mm surgery setting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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David Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Dean A. McGee Eye Institute
Locations
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Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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Phacoemulsification Sleeves
Identifier Type: -
Identifier Source: org_study_id