A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

• Registration Number: NCT01684007
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.

Detailed Description

Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-12
• Study Start: 2012-11
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-05
• Results First Submitted: 2015-05-08
• Results First Submitted QC: 2015-05-08
• Last Update Submitted: 2015-05-26
• Results First Posted: 2015-05-27
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
• Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
• Willing to have second eye surgery within 45 days of first eye surgery;
• Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
• Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
• Significant irregular corneal astigmatism as demonstrated by corneal topography;
• Severe degenerative visual disorders;
• Previous corneal surgery;
• Amblyopia;
• Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;
• History of corneal disease;
• Severe diabetic retinopathy;
• History of retinal detachment;
• Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
• Pregnant or planning pregnancy during course of study;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contralateral	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation
Bilateral	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation
Contralateral	AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation

Primary Outcome Measures

Name	Time	Method
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)	Day 90 from second eye implantation	Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)	Day 90 from second eye implantation	VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.