Phacoemulsification Sleeves

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00289068
First received: February 7, 2006
Last updated: July 8, 2011
Last verified: July 2011

February 7, 2006
July 8, 2011
January 2006
April 2006   (final data collection date for primary outcome measure)
Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity
Complete list of historical versions of study NCT00289068 on ClinicalTrials.gov Archive Site
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Phacoemulsification Sleeves
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Dean A. McGee Eye Institute

Cataract
  • Procedure: Phacoemulsification Sleeve surgery
    Group 2.2 mm surgery setting
    Other Names:
    • Phacoemulsification Sleeve setting 2.2 mm
    • Procedure/Surgery: Phacoemulsification Sleeves surgery
  • Procedure: Phacoemulsification Sleeves surgery
    Group 2.8 mm surgery setting
    Other Names:
    • Phacoemulsification Sleeve setting 2.8mm
    • Procedure/Surgery: Phacoemulsification Sleeves surgery
  • Procedure: Phacoemulsification Sleeves
    Group 3.0 mm surgery setting
    Other Names:
    • Phacoemulsification Sleeve setting 3.0 mm
    • Procedure/Surgery: Phacoemulsification Sleeves surgery
  • Phacoemulsification Sleeve 2.2mm
    Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
    Intervention: Procedure: Phacoemulsification Sleeve surgery
  • Phacoemulsification Sleeve 2.8mm
    Phacoemulsification Sleeve setting 2.8 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
    Intervention: Procedure: Phacoemulsification Sleeves surgery
  • Phacoemulsification Sleeve 3.0mm
    Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
    Intervention: Procedure: Phacoemulsification Sleeves
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2007
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • requiring cataract surgery

Exclusion Criteria:

  • n/a
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00289068
Phacoemulsification Sleeves
Yes
Determination of Surgical Efficiency and most Efficient Surgical Parameters for use with the 2.2, 2.8, and 3.0 mm Phacoemulsification Sleeves used with the Alcon Infinity 1.1 mm ABS Flared Tip, Dean A. McGee Eye Institute
University of Oklahoma
Not Provided
Principal Investigator: David Jackson, MD Dean A. McGee Eye Institute
University of Oklahoma
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP