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NCT01279031 Clinical Trial

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

Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01279031
Other study ID # Abbott2010-Whitestar
Secondary ID
Status Completed
Phase Phase 4
First received January 14, 2011
Last updated January 13, 2012
Start date October 2011
Est. completion date January 2012

Study information
Verified date January 2012
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Comparison of vision after cataract surgery based on two different types of equipment.
• Alcon Infiniti wiht the OZIL Torsional Handpiece
Comparision of vision after cataract surgery based on two different types of equipment.

Locations
Country Name City State
United States Kerry Assil Beverly Hills California

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 1 year No
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