Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: AcrySof® ReSTOR® Aspheric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00934622

ALCONsur002.07

Details and patient eligibility

About

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Enrollment: 76 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 21 years or older;
• need spherical correction between 10-30 Diopters (D);
• corneal astigmatism less than 0.75D as measured by keratometry;
• willing to sign an Informed Consent Form and complete all visits;
• pupil dilation greater than 6mm;
• expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion criteria

• Women of childbearing potential;
• irregular corneal astigmatism;
• keratopathy/keratectasia;
• cornea inflammation or edema;
• cornea reshaping surgery;
• corneal dystrophy;corneal transplant;
• amblyopia;
• glaucoma;
• Retinal Pigment Epitheliopathy (RPE)/Macular changes;
• proliferative diabetic retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

AcrySof® ReSTOR® Aspheric IOL

Experimental group

Description:

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)

Treatment:

Device: AcrySof® ReSTOR® Aspheric IOL