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

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01279031
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts; Astigmatism	Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound; Device: Alcon Infiniti wiht the OZIL Torsional Handpiece	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual acuity [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kerry Assil	Beverly Hills	California	United States

Sponsors and Collaborators

• Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01279031
• Other Study ID Numbers: Abbott2010-Whitestar
• First Posted: Jan 19, 2011
• Last Update Posted: Jan 18, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Jan 18, 2012