Postmarket Study of an Intraocular Lens Power Selection System

April 3, 2020 updated by: Alcon Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Mount Dora, Florida, United States, 32757
        • Alcon Investigative Site
      • Panama City, Florida, United States, 32405
        • Alcon Investigative Site
    • New York
      • Poughkeepsie, New York, United States, 12603
        • Alcon Investigative Site
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Alcon Investigative Site
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Alcon Investigative Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Alcon Investigative Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Alcon Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Alcon Investigative Site
    • Texas
      • Nacogdoches, Texas, United States, 75965
        • Alcon Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned cataract surgery with IOL implantation
  • Able to comprehend and sign the informed consent form
  • Preoperative astigmatism of 0.75 to 3.00 Diopter
  • Willing and able to complete all required postoperative visits
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Unclear intraocular media other than cataract
  • Pregnant or lactating
  • Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
  • Other protocol-defined exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ORA with VerifEye+
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
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.
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)
Active Comparator: Barrett Toric Calculator
First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Time Frame: Month 6
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Operations Lead, Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILX369-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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