AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

Study Overview
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Brief Summary
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The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Detailed Description
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This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Official Title
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AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

Conditions
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Cataract

Intervention / Treatment
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* Device: Panoptix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option Gender: Males and Females. Age: 40 or older. Willing and able to provide written informed consent for participation in the study. Willing and able to comply with scheduled visits and other study procedures. Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens. Have 20/32 (0.2 logMAR) or better potential acuity in both eyes Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye) Monocular status (e.g. amblyopia) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Diabetic retinopathy Macular pathology (e.g. age-related macular degeneration, epiretinal membrane) History of retinal detachment Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Panoptix<br>Bilateral implantation of the Panoptix trifocal IOL | Device: Panoptix<br>* Panoptix trifocal intraocular lens (IOL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Have Spectacle Independence | Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - a little of the time or none of the time) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity in logMAR | 3 months | 
| Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate visual acuity in logMAR | 3 months | 
| Binocular Uncorrected Near Visual Acuity | Binocular logMAR uncorrected near visual acuity | 3 months | 
| Binocular Best-corrected Distance Visual Acuity | Binocular logMAR best-corrected distance visual acuity | 3 months | 
| Binocular Distance-corrected Intermediate Visual Acuity | Binocular distance-corrected logMAR intermediate visual acuity | 3 months | 
| Binocular Distance-corrected Near Visual Acuity | Binocular logMAR distance-corrected near visual acuity | 3 months | 
| Spherical Equivalent Refraction | Spherical equivalent refraction in diopters | 3 months | 
| Residual Refractive Cylinder | Residual refractive cylinder in diopters | 3 months | 
| Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup | Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panoptix, Trifocal IOL, Multifocal IOL