NCT03579433

Postmarket Study of an Intraocular Lens Power Selection System

Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Detailed description

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	ORA with VerifEye+	Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.
OTHER	Alcon Barrett Toric Calculator	Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.
DEVICE	Acrysof® IQ Toric IOL	Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)

Timeline

• Start date: 2018-08-16
• Primary completion: 2019-04-16
• Completion: 2019-04-16
• First posted: 2018-07-06
• Last updated: 2020-04-07
• Results posted: 2020-04-07

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study