Back to resultsComparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems
Primary Purpose
Cataract Extraction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Legacy 20000
Infinit system
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Extraction
Eligibility Criteria
Inclusion Criteria: Cataract Eligible for cataract extraction with primary implantation of a posterior chamber IOL 2 to 3+ cataract density Exclusion Criteria: Preoperative ocular pathology that can affect visual acuity Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities. Previous intraocular or corneal surgery. Other ocular surgery at the time of the cataract extraction. Surgical Exclusion Criteria: Significant intraoperative intraocular bleeding Detached Descemet's membrane Implantation of the intraocular lens in the anterior chamber or sulcus
Sites / Locations
Outcomes
Primary Outcome Measures
Ultrasound time
Amount of fluid used
Post operative visual acuity.
Secondary Outcome Measures
Full Information
NCT ID
NCT00366665
First Posted
August 17, 2006
Last Updated
August 17, 2006
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00366665
Brief Title
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems
Official Title
Comparison of the Infiniti Vision and the Series 20000 Legacy Systems
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
4. Oversight
5. Study Description
Brief Summary
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Legacy 20000
Intervention Type
Device
Intervention Name(s)
Infinit system
Primary Outcome Measure Information:
Title
Ultrasound time
Title
Amount of fluid used
Title
Post operative visual acuity.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract
Eligible for cataract extraction with primary implantation of a posterior chamber IOL
2 to 3+ cataract density
Exclusion Criteria:
Preoperative ocular pathology that can affect visual acuity
Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
Previous intraocular or corneal surgery.
Other ocular surgery at the time of the cataract extraction.
Surgical Exclusion Criteria:
Significant intraoperative intraocular bleeding
Detached Descemet's membrane
Implantation of the intraocular lens in the anterior chamber or sulcus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D. Solomon, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems
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