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Phacoemulsification Sleeves

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289068
First Posted: February 9, 2006
Last Update Posted: July 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oklahoma
  Purpose
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.

Condition Intervention
Cataract Procedure: Phacoemulsification Sleeve surgery Procedure: Phacoemulsification Sleeves surgery Procedure: Phacoemulsification Sleeves

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity [ Time Frame: 2 years ]

Enrollment: 44
Study Start Date: January 2006
Study Completion Date: September 2007
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phacoemulsification Sleeve 2.2mm
Phacoemulsification Sleeve setting 2.2 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Procedure: Phacoemulsification Sleeve surgery
Group 2.2 mm surgery setting
Other Names:
  • Phacoemulsification Sleeve setting 2.2 mm
  • Procedure/Surgery: Phacoemulsification Sleeves surgery
Phacoemulsification Sleeve 2.8mm
Phacoemulsification Sleeve setting 2.8 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
Phacoemulsification Sleeve 3.0mm
Phacoemulsification Sleeve setting 3.0 mm 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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dean A. McGee Eye Institute
Criteria

Inclusion Criteria:

  • requiring cataract surgery

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289068


Locations
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: David Jackson, MD Dean A. McGee Eye Institute
  More Information

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00289068     History of Changes
Other Study ID Numbers: Phacoemulsification Sleeves
First Submitted: February 7, 2006
First Posted: February 9, 2006
Last Update Posted: July 11, 2011
Last Verified: July 2011

Keywords provided by University of Oklahoma:
cataract surgery
phacoemulsification sleeve

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases