A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1; Device: Acri.LISA® 366D IOL; Device: Acri.LISA® 466TD Toric IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257217

M09-051

Details and patient eligibility

About

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Full description

Each subject completed 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 Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign informed consent;
• Able to attend postoperative examinations per protocol schedule;
• Diagnosed with bilateral cataracts;
• Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
• Preoperative astigmatism ≤ 2.5 diopter;
• Good ocular health, with the exception of cataracts;
• Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
• Able to undergo second eye surgery within one month of the first eye surgery;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Previous corneal surgery;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Any ocular disease and/or condition that may compromise study results;
• Pregnant or planning pregnancy during course of study;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
• Diabetic retinopathy;
• Macular degeneration;
• History of retinal detachment;
• 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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31 participants in 2 patient groups

ReSTOR +3

Experimental group

Description:

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation

Treatment:

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

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

Acri.LISA

Active Comparator group

Description:

Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation

Treatment:

Device: Acri.LISA® 466TD Toric IOL

Device: Acri.LISA® 366D IOL