NCT03274986

A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)

A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

Detailed description

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	ACRYSOF® IQ Extended Depth of Focus IOL	Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.
DEVICE	ACRYSOF® IQ Monofocal IOL	Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
PROCEDURE	Cataract surgery	IOL bilateral implantation

Timeline

• Start date: 2017-10-11
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2017-09-07
• Last updated: 2020-04-07
• Results posted: 2020-04-07

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study