Phacoemulsification Sleeves
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

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.
    

Intervention name(s): Phacoemulsification Sleeve surgery; Phacoemulsification Sleeves surgery; Phacoemulsification Sleeves
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Group 2.2 mm surgery setting; Group 2.8 mm surgery setting; Group 3.0 mm surgery setting
Other intervention name(s): Phacoemulsification Sleeve setting 2.2 mm; Procedure/Surgery: Phacoemulsification Sleeves surgery; Phacoemulsification Sleeve setting 2.8mm; Procedure/Surgery: Phacoemulsification Sleeves surgery; Phacoemulsification Sleeve setting 3.0 mm; Procedure/Surgery: Phacoemulsification Sleeves surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dean A. McGee Eye Institute
      
Keywords: cataract surgery; phacoemulsification sleeve