NCT03090256

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Detailed description

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	AcrySof® IQ PanOptix™ IOL	Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Timeline

• Start date: 2017-04-11
• Primary completion: 2018-02-13
• Completion: 2018-02-13
• First posted: 2017-03-24
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated device study