Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: Monofocal IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290068

RDG-10-269

Details and patient eligibility

About

The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

Full description

This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Enrollment: 208 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to understand and sign an Informed Consent;
• Willing and able to attend post-operative examinations as per protocol schedule;
• Diagnosis of bilateral, age-related cataracts;
• Planned cataract removal via phacoemulsification with implantation of an IOL;
• Available to undergo second eye surgery within 6 weeks of the first eye surgery;
• Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
• No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
• Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
• Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Previous corneal surgery and/or reshaping;
• Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
• Pregnant, lactating, or planning pregnancy during the 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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208 participants in 3 patient groups

ReSTOR +3

Experimental group

Description:

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation

Treatment:

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

ReSTOR +3 Toric

Experimental group

Description:

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye

Treatment:

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

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

Monofocal

Active Comparator group

Description:

Monofocal IOL, bilateral implantation

Treatment:

Device: Monofocal IOL