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|ClinicalTrials.gov Identifier: NCT00289068|
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : July 11, 2011
|Condition or disease||Intervention/treatment|
|Cataract||Procedure: Phacoemulsification Sleeve surgery Procedure: Phacoemulsification Sleeves surgery Procedure: Phacoemulsification Sleeves|
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.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|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|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||September 2007|
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
- Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|