NCT01510717

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cataracts

Interventions

Type	Name	Description
DEVICE	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
DEVICE	AcrySof® IQ Monofocal IOL Model SN60WF	Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-01-16
• Last updated: 2015-05-27
• Results posted: 2015-05-27