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

NCT ID: NCT01684007

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Cataracts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bilateral

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Intervention Type: DEVICE

Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

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

Group Type: ACTIVE_COMPARATOR

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Intervention Type: DEVICE

Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Intervention Type: DEVICE

Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magda Michna, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-12-007

Identifier Type: -

Identifier Source: org_study_id