NCT01424189

Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Detailed description

Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Conditions

• Cataracts

Interventions

Type	Name	Description
DEVICE	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL	Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
DEVICE	AcrySof® ReSTOR® Multifocal IOL Model SA60D3	Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-08-26
• Last updated: 2018-06-29
• Results posted: 2017-03-06