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

Alcon Research

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cataract

Interventions

AcrySof® Toric IOLDEVICE

Implanted into the study eye

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alcon Call Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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