Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: AcrySof® ReSTOR® Aspheric IOL

• Registration Number: NCT00934622
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-03
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Results First Submitted: 2010-03-25
• Status Verified: 2010-05
• Results First Submitted QC: 2010-05-05
• Last Update Submitted: 2010-05-05
• Results First Posted: 2010-05-06
• Last Update Posted: 2010-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AcrySof® ReSTOR® Aspheric IOL	AcrySof® ReSTOR® Aspheric IOL	AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)

Primary Outcome Measures

Name	Time	Method
Visual Acuity	pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery	Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Spectacle Independence	pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery	Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States