NCT00721253

Brief Summary

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2007

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

1.3 years

First QC Date

July 21, 2008

Results QC Date

September 18, 2009

Last Update Submit

March 4, 2010

Conditions

Cataract

Keywords

ReSTOR

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate

    Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

    6 months

Secondary Outcomes (2)

  • Contrast Sensitivity

    6 months

  • Defocus Curve

    6 months post-operative

Study Arms (3)

ReSTOR Aspheric +4

ACTIVE COMPARATOR

ACRYSOF ReSTOR Aspheric +4 Model SN6AD3

Device: ReSTOR

Tecnis MF

ACTIVE COMPARATOR

Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900

Device: Tecnis

Acri.LISA

ACTIVE COMPARATOR

Meditec Acri.LISA Intraocular Lens (IOL) Model 366D

Device: Acri.LISA

Interventions

ReSTORDEVICE

Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)

ReSTOR Aspheric +4
TecnisDEVICE

Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)

Tecnis MF
Acri.LISADEVICE

Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)

Acri.LISA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with cataracts

You may not qualify if:

  • Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 24, 2008

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 16, 2010

Results First Posted

March 16, 2010

Record last verified: 2010-03

Locations

US(1)