NCT03280108

Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

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 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 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 PanOptix Multifocal IOL	AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
DEVICE	AcrySof Monofocal IOL	AcrySof Monofocal IOL Model SN60AT for single vision

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-09-27
• Completion: 2018-09-27
• First posted: 2017-09-12
• Last updated: 2019-10-10
• Results posted: 2019-10-10

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study