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

NCT ID: NCT01279031

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cataracts Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abbott WHITESTAR Signature System

Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound

Group Type EXPERIMENTAL

Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound

Intervention Type DEVICE

Comparison of vision after cataract surgery based on two different types of equipment.

Alcon Infiniti

Alcon Infiniti with the OZIL Torsional Handpiece

Group Type EXPERIMENTAL

Alcon Infiniti wiht the OZIL Torsional Handpiece

Intervention Type DEVICE

Comparision of vision after cataract surgery based on two different types of equipment.

Interventions

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Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound

Comparison of vision after cataract surgery based on two different types of equipment.

Intervention Type DEVICE

Alcon Infiniti wiht the OZIL Torsional Handpiece

Comparision of vision after cataract surgery based on two different types of equipment.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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CRO

Locations

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Kerry Assil

Beverly Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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Abbott2010-Whitestar

Identifier Type: -

Identifier Source: org_study_id

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