Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial

January 13, 2012 updated by: Innovative Medical
The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
        • Kerry Assil

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs.
  • Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm).
  • Visual potential of UCVA 20/25/ or better.
  • Clear intraocular media other than cataract.

Exclusion Criteria:

  • Clinically relevant differences between eyes in ocular disease or pathology.
  • Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree.
  • Asymmetrical use of ocular medications.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Abbott WHITESTAR Signature System
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Comparison of vision after cataract surgery based on two different types of equipment.
EXPERIMENTAL: Alcon Infiniti
Alcon Infiniti with the OZIL Torsional Handpiece
Device: Alcon Infiniti wiht the OZIL Torsional Handpiece
Comparision of vision after cataract surgery based on two different types of equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

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

October 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Abbott2010-Whitestar

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.

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