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OpenTrials
Completed

NCT Number: NCT00289068

Phacoemulsification Sleeves

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • requiring cataract surgery

Exclusion criteria

  • n/a

Treatment and study plan

Phacoemulsification Sleeve surgery

Procedure

Group 2.2 mm surgery setting

Other names: Phacoemulsification Sleeve setting 2.2 mm, Procedure/Surgery: Phacoemulsification Sleeves surgery

Phacoemulsification Sleeves surgery

Procedure

Group 2.8 mm surgery setting

Other names: Phacoemulsification Sleeve setting 2.8mm, Procedure/Surgery: Phacoemulsification Sleeves surgery

Phacoemulsification Sleeves

Procedure

Group 3.0 mm surgery setting

Other names: Phacoemulsification Sleeve setting 3.0 mm, Procedure/Surgery: Phacoemulsification Sleeves surgery

Primary outcomes

  1. Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Feb 9, 2006
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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