NCT01684007

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

Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

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 ReSTOR® +3.0 D Multifocal IOL Model SN6AD1	Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-09-12
• Last updated: 2015-06-22
• Results posted: 2015-05-27