Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems

This study has been completed.

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00366665

Purpose

To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.

Condition	Intervention
Cataract Extraction	Device: Legacy 20000 Device: Infinit system

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Comparison of the Infiniti Vision and the Series 20000 Legacy Systems

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Ultrasound time
Amount of fluid used
Post operative visual acuity.

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366665

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Kerry D. Solomon, MD

Medical University of South Carolina

More Information

Study ID Numbers:	MRC-05-002
Study First Received:	August 17, 2006
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00366665
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009