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

Phase 4

Completed

• Conditions: Cataracts; Astigmatism
• Interventions: Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound; Device: Alcon Infiniti wiht the OZIL Torsional Handpiece

• Registration Number: NCT01279031
• Lead Sponsor: Innovative Medical

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Study Start: 2011-10
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abbott WHITESTAR Signature System	Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound	Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Alcon Infiniti	Alcon Infiniti wiht the OZIL Torsional Handpiece	Alcon Infiniti with the OZIL Torsional Handpiece

Primary Outcome Measures

Name	Time	Method
Visual acuity	1 year

Trial Locations

Locations (1)

Kerry Assil; 🇺🇸 Beverly Hills, California, United States