Phacoemulsification Sleeves

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Phacoemulsification Sleeve surgery
* Procedure: Phacoemulsification Sleeves surgery
* Procedure: Phacoemulsification Sleeves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: requiring cataract surgery Exclusion Criteria: n/a

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phacoemulsification Sleeve 2.2mm<br>Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery | Procedure: Phacoemulsification Sleeve surgery<br>* Group 2.2 mm surgery setting<br>* Other names: Procedure/Surgery: Phacoemulsification Sleeves surgery;|
| Phacoemulsification Sleeve 2.8mm<br>Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery | Procedure: Phacoemulsification Sleeves surgery<br>* Group 2.8 mm surgery setting<br>* Other names: Procedure/Surgery: Phacoemulsification Sleeves surgery;|
| Phacoemulsification Sleeve 3.0mm<br>Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery | Procedure: Phacoemulsification Sleeves<br>* Group 3.0 mm surgery setting<br>* Other names: Procedure/Surgery: Phacoemulsification Sleeves surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, phacoemulsification sleeve