Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289068
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2006-02-07
Brief Title:
Phacoemulsification Sleeves
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Determination of Surgical Efficacy and Most Efficient Surgical Parameters for Use With the 22 28 and 30mm Phacoemulsification Sleeves Used With the Alcon Infinity 11mm ABS Flared Tip
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Incision size in cataract surgery is related to induced surgical astigmatism chamber stability and surgical efficiency Sleeves of different diameters change the size of the surgical incision and amount of fluid allowed into the eye during the surgical procedure for a given set of surgical parameters Optimization of surgical parameters requires review of surgical efficiency including fluid usage energy usage and total surgical time With optimized surgical parameters recommendations can be made to increase the efficiency and safety of cataract surgery
Detailed Description:
No scientific data has been presented comparing the surgical efficiency of the 22 28 and 30 mm diameter phacoemulsification sleeves for the Alcon Infinity 11 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 22 28 and 30 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 phacoemulsificationtorsional timepower 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 andor best corrected visual acuity
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 22 28 and 30 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 phacoemulsificationtorsional timepower 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 andor best corrected visual acuity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None