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

Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye

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.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral; AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Active Comparator: Contralateral; AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1; Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)	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.	Day 90 from second eye implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)	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.	Day 90 from second eye implantation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Magda Michna, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Intraocular lens; Multifocal intraocular lens (MIOL)
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: M-12-007