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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01279031
First received: January 14, 2011
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Cataracts
Astigmatism
Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
Device: Alcon Infiniti wiht the OZIL Torsional Handpiece
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279031

Locations
United States, California
Kerry Assil
Beverly Hills, California, United States
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Melissa Earl, CRO
ClinicalTrials.gov Identifier: NCT01279031     History of Changes
Other Study ID Numbers: Abbott2010-Whitestar
Study First Received: January 14, 2011
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases
Salicylic Acid
Dipivefrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014