Phacoemulsification Sleeves
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
1 other identifier
observational
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 15, 2023
December 1, 2023
3 months
February 7, 2006
December 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total surgical time, fluid volume, energy used to extract the cataract, post-operative cell and flare and corneal clarity
2 years
Study Arms (3)
Phacoemulsification Sleeve 2.2mm
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
Phacoemulsification Sleeve 3.0mm
Phacoemulsification Sleeve setting 3.0 mm Procedure/Surgery: Phacoemulsification Sleeves surgery
Interventions
Group 2.2 mm surgery setting
Group 2.8 mm surgery setting
Group 3.0 mm surgery setting
Eligibility Criteria
Dean A. McGee Eye Institute
You may qualify if:
- requiring cataract surgery
You may not qualify if:
- n/a
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Jackson, MD
Dean A. McGee Eye Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
January 1, 2006
Primary Completion
April 1, 2006
Study Completion
September 1, 2007
Last Updated
December 15, 2023
Record last verified: 2023-12