A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: ReSTOR +3; Device: Tecnis MF

• Registration Number: NCT01166971
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2011-03
• 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: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• diagnosed with bilateral cataracts
• candidate for presbyopic lens

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Exclusion Criteria

• >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
• pre-existing conditions that could skew the results

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSTOR +3	ReSTOR +3	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
Tecnis MF	Tecnis MF	Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction

Primary Outcome Measures

Name	Time	Method
Defocus Curve	3 months after surgery	A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".

Trial Locations

Locations (3)

The Eye Center of North Florida; 🇺🇸 Panama City, Florida, United States

Whitsett Vision Group; 🇺🇸 Houston, Texas, United States

Carolina Eye Care Physicians; 🇺🇸 Charleston, South Carolina, United States