Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Phase 4

Terminated

• Conditions: Cataract
• Interventions: Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3

• Registration Number: NCT00710905
• Lead Sponsor: Alcon Research

Brief Summary

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-10-04
• Results First Submitted QC: 2011-10-04
• Status Verified: 2011-11
• Results First Posted: 2011-11-08
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria

• Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
• All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSTOR	AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3	Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.

Primary Outcome Measures

Name	Time	Method
Binocular Visual Acuity at Near, Intermediate and Distance	6 months after surgery	Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Trial Locations

Locations (2)

Dr Dominique Meyer; 🇨🇦 Quebec City, Quebec, Canada

Dr John Blaylock; 🇨🇦 Abbotsford, British Columbia, Canada