Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: AcrySof® IQ Monofocal IOL Model SN60WF; Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510717

C-10-016

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Full description

Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

Enrollment: 409 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of bilateral cataracts
• Willing and able to complete all required postoperative visits
• Calculated lens power within the available supply range
• Planned cataract removal by phacoemulsification
• Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
• Preoperative astigmatism less than 1.0 diopter
• Clear intraocular media other than cataract in study eyes
• Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
• Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Previous refractive surgery
• Inflammation or edema of the cornea
• Optic nerve atrophy
• Pregnancy
• Current participation in another investigational drug or device study
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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409 participants in 2 patient groups

Multifocal IOL

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]

Monofocal IOL

Active Comparator group

Description:

AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation

Treatment:

Device: AcrySof® IQ Monofocal IOL Model SN60WF