Phacoemulsification Sleeves
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 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 3.0mm Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery |
Procedure: Phacoemulsification Sleeves
Group 3.0 mm surgery setting
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
- requiring cataract surgery
Exclusion Criteria:
- n/a
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Phacoemulsification Sleeves