Presbyopia-Correcting Intraocular Lenses (IOLs)

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: ReSTOR +3; Device: Crystalens HD; Device: Crystalens AO

• Registration Number: NCT00963560
• 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 Presbyopia-Correcting Intraocular Lenses (IOLs).

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: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2011-03
• Status Verified: 2011-07
• Results First Submitted: 2011-07-13
• Results First Submitted QC: 2011-07-13
• Last Update Submitted: 2011-07-13
• Results First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• diagnosed with bilateral cataracts
• candidate for presbyopic lens

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Exclusion Criteria

• > 1 Diopter preoperative astigmatism by Keratometry 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 Lens (IOL)
Crystalens HD	Crystalens HD	Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Crystalens AO	Crystalens AO	Bilateral implantation of Crystalens AO Intraocular Lens (IOL)

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	6 Months after surgery	Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) 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 visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Trial Locations

Locations (1)

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