Phacoemulsification Sleeves

December 8, 2023 updated by: University of Oklahoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Dean A. McGee Eye Institute

Description

Inclusion Criteria:

  • requiring cataract surgery

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • Procedure/Surgery: Phacoemulsification Sleeves surgery
  • Phacoemulsification Sleeve setting 2.8mm
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:
  • Procedure/Surgery: Phacoemulsification Sleeves surgery
  • Phacoemulsification Sleeve setting 3.0 mm

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: David Jackson, MD, Dean A. McGee Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimated)

February 9, 2006

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phacoemulsification Sleeves

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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