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
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dean A. McGee Eye Institute

Criteria

Inclusion Criteria:

  • requiring cataract surgery

Exclusion Criteria:

  • n/a
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 7, 2006
Last Updated: July 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
cataract surgery
phacoemulsification sleeve

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 21, 2014