ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens; Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

• Registration Number: NCT00684138
• Lead Sponsor: Alcon Research

Brief Summary

Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-01-30
• Results First Submitted QC: 2010-02-23
• Results First Posted: 2010-03-11
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReSTOR Aspheric +3.0D	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
ReSTOR Aspheric +4.0D	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Primary Outcome Measures

Name	Time	Method
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)	3 months	Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

Secondary Outcome Measures

Name	Time	Method
Binocular Distance Corrected Distance Visual Acuity	3 months post-operative	Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)	3 months post-operative	Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)	3 months post-operative	Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)	3 months post-operative	Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Trial Locations

Locations (1)

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