Postmarket Study of an Intraocular Lens Power Selection System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: ORA with VerifEye+
* Other: Alcon Barrett Toric Calculator
* Device: Acrysof® IQ Toric IOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORA with VerifEye+<br>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+<br>* 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.<br>Device: Acrysof® IQ Toric IOL<br>* Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)<br>|
| Active Comparator: Barrett Toric Calculator<br>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. | Other: Alcon Barrett Toric Calculator<br>* 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.<br>Device: Acrysof® IQ Toric IOL<br>* Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, Intraocular lens, Astigmatism, Cataract Surgery