MedTrace Logo

Postmarket Study of an Intraocular Lens Power Selection System

NCT03579433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-04-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Cataract

Interventions

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)

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Operations Lead, Surgical · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2019-04-16
Completion
2019-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579433 on ClinicalTrials.gov