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

Alcon

Status and phase: Withdrawn; Phase 4

Conditions: Cataract

Treatments: Device: AcrySof® Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761488

HK-Toric-YIU-01

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

AcrySof® Toric IOL

Treatment:

Device: AcrySof® Toric IOL