NCT00761488

Brief Summary

To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
Last Updated

May 12, 2015

Status Verified

January 1, 2010

First QC Date

September 25, 2008

Last Update Submit

May 8, 2015

Conditions

Cataract

Keywords

Visual acuity,corneal andrefractivecylinderfollowingimplantation of theAcrySof® Toric

Outcome Measures

Primary Outcomes (1)

  • Corneal astigmatism; IOL rotation

    Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.

Secondary Outcomes (1)

  • Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)

    Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.

Study Arms (1)

1

EXPERIMENTAL

AcrySof® Toric IOL

Device: AcrySof® Toric IOL

Interventions

AcrySof® Toric IOLDEVICE

Implanted into the study eye

1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

You may not qualify if:

  • Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases
0

Study Design

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

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Last Updated

May 12, 2015

Record last verified: 2010-01

Locations

US(1)