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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

I

Innovative Medical

Status and phase

Completed
Phase 4

Conditions

Astigmatism
Cataracts

Treatments

Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Device: Alcon Infiniti wiht the OZIL Torsional Handpiece

Study type

Interventional

Funder types

Industry

Identifiers

NCT01279031
Abbott2010-Whitestar

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Abbott WHITESTAR Signature System
Experimental group
Description:
Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Treatment:
Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Alcon Infiniti
Experimental group
Description:
Alcon Infiniti with the OZIL Torsional Handpiece
Treatment:
Device: Alcon Infiniti wiht the OZIL Torsional Handpiece

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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