NCT01279031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

January 14, 2011

Last Update Submit

January 13, 2012

Conditions

CataractsAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    1 year

Study Arms (2)

Abbott WHITESTAR Signature System

EXPERIMENTAL

Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound

Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound

Alcon Infiniti

EXPERIMENTAL

Alcon Infiniti with the OZIL Torsional Handpiece

Device: Alcon Infiniti wiht the OZIL Torsional Handpiece

Interventions

Abbott WHITESTAR Signature System with Ellips Transversal UltrasoundDEVICE

Comparison of vision after cataract surgery based on two different types of equipment.

Abbott WHITESTAR Signature System
Alcon Infiniti wiht the OZIL Torsional HandpieceDEVICE

Comparision of vision after cataract surgery based on two different types of equipment.

Alcon Infiniti

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerry Assil

Beverly Hills, California, United States

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

US(1)