- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00366665
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems
August 17, 2006 updated by: Medical University of South Carolina
Comparison of the Infiniti Vision and the Series 20000 Legacy Systems
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Not Applicable
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Ultrasound time
|
|
Amount of fluid used
|
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Post operative visual acuity.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kerry D. Solomon, MD, Medical University of South Carolina
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
March 1, 2005
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
August 17, 2006
First Submitted That Met QC Criteria
August 17, 2006
First Posted (Estimate)
August 21, 2006
Study Record Updates
Last Update Posted (Estimate)
August 21, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
May 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRC-05-002
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.