NCT04098367

Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

Detailed description

A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	VIVITY	Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction
DEVICE	SYMFONY	Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed
DEVICE	AT LARA	Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction
PROCEDURE	Cataract surgery	Cataract removal by routine small incision surgery

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-05-03
• Completion: 2021-07-22
• First posted: 2019-09-23
• Last updated: 2022-05-04
• Results posted: 2022-05-04

Locations

12 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated device study