Phacoemulsification Sleeves

University of Oklahoma (OU)

Status: Completed

Conditions: Cataract

Treatments: Procedure: Phacoemulsification Sleeves surgery; Procedure: Phacoemulsification Sleeve surgery; Procedure: Phacoemulsification Sleeves

Study type: Observational

Funder types: Other

Identifiers

NCT00289068

Phacoemulsification Sleeves

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• requiring cataract surgery

Exclusion criteria

• n/a

Trial design

44 participants in 3 patient groups

Phacoemulsification Sleeve 2.2mm

Description:

Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery

Treatment:

Procedure: Phacoemulsification Sleeve surgery

Phacoemulsification Sleeve 2.8mm

Description:

Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery

Treatment:

Procedure: Phacoemulsification Sleeves surgery

Phacoemulsification Sleeve 3.0mm

Description:

Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery

Treatment:

Procedure: Phacoemulsification Sleeves