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

Sponsor

Alcon Research (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00761488

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof® Toric IOL	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AcrySof® Toric IOL	Device: AcrySof® Toric IOL Implanted into the study eye

Arm

Intervention/Treatment

Experimental: 1

AcrySof® Toric IOL

Device: AcrySof® Toric IOL

Implanted into the study eye

Outcome Measures

Primary Outcome Measures

Corneal astigmatism; IOL rotation [Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.