Phacoemulsification Sleeves

Completed

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification Sleeves surgery; Procedure: Phacoemulsification Sleeves; Procedure: Phacoemulsification Sleeve surgery

• Registration Number: NCT00289068
• Lead Sponsor: University of Oklahoma

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 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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2006-04
• Study Completion: 2007-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• requiring cataract surgery

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phacoemulsification Sleeve 2.8mm	Phacoemulsification Sleeves surgery	Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeve 3.0mm	Phacoemulsification Sleeves	Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeve 2.2mm	Phacoemulsification Sleeve surgery	Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery

Primary Outcome Measures

Name	Time	Method
Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity	2 years

Trial Locations

Locations (1)

Dean A. McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States