Postmarket Study of an Intraocular Lens Power Selection System

Completed · Not applicable

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT03579433

Run by

Alcon Research

People needed

124

Starts

2018-08-16

Expected to finish

2019-04-16

Last updated by the study team

2020-04-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alcon Investigative Site — Mt. Dora, Florida, United States
• Alcon Investigative Site — Panama City, Florida, United States
• Alcon Investigative Site — Poughkeepsie, New York, United States
• Alcon Investigative Site — Kingston, Pennsylvania, United States
• Alcon Investigative Site — Florence, South Carolina, United States
• Alcon Investigative Site — Mt. Pleasant, South Carolina, United States
• Alcon Investigative Site — Sioux Falls, South Dakota, United States
• Alcon Investigative Site — Nashville, Tennessee, United States
• Alcon Investigative Site — Nacogdoches, Texas, United States

Full record on ClinicalTrials.gov

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