|Cataract||Procedure: Phacoemulsification Sleeve surgery Procedure: Phacoemulsification Sleeves surgery Procedure: Phacoemulsification Sleeves|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Determination of Surgical Efficacy and Most Efficient Surgical Parameters for Use With the 2.2, 2.8, and 3.0mm Phacoemulsification Sleeves Used With the Alcon Infinity 1.1mm ABS Flared Tip|
- Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity [ Time Frame: 2 years ]
|Study Start Date:||January 2006|
|Study Completion Date:||September 2007|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Phacoemulsification Sleeve 2.2mm
Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Procedure: Phacoemulsification Sleeve surgery
Group 2.2 mm surgery setting
Phacoemulsification Sleeve 2.8mm
Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Procedure: Phacoemulsification Sleeves surgery
Group 2.8 mm surgery setting
Phacoemulsification Sleeve 3.0mm
Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Procedure: Phacoemulsification Sleeves
Group 3.0 mm surgery setting
No scientific data has been presented comparing the surgical efficiency of the 2.2, 2.8, and 3.0 mm diameter phacoemulsification sleeves for the Alcon Infinity 1.1 mm flare abs tip or the changes in surgical parameters which optimize their performance. Fifty patients per sleeve group will undergo standard cataract extraction with documentation of surgical parameters used for each group. 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289068
|United States, Oklahoma|
|Dean A. McGee Eye Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||David Jackson, MD||Dean A. McGee Eye Institute|