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

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01684007

M-12-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Bilateral

Experimental group

Description:

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

Treatment:

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

Contralateral

Active Comparator group

Description:

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation

Treatment:

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

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