Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric

This study is not yet open for participant recruitment.

Verified by Alcon Research, September 2008

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00761488

Purpose

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.

Condition	Intervention	Phase
Cataract	Device: AcrySof® Toric IOL	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Corneal astigmatism; IOL rotation [ Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Uncorrected and best distance corrected visual acuities (UCVA and BDCVA) [ Time Frame: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AcrySof® Toric IOL	Device: AcrySof® Toric IOL Implanted into the study eye

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

40-80 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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761488

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon Research Ltd. ( Ricky Ho, RA Manager )
Study ID Numbers:	HK-Toric-YIU-01
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761488
Health Authority:	China: Ethics Committee

Keywords provided by Alcon Research:

Visual acuity,
corneal and
refractive
cylinder

following
implantation of the
AcrySof® Toric

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009