Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Study Overview
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Brief Summary
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The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

Detailed Description
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This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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 visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Official Title
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Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye

Conditions
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Cataract

Intervention / Treatment
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* Device: Vivity Extended Depth of Focus intraocular lens (IOL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL Meet the requirements for on-label implantation of the EDF IOL 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 toric IOL. Have 20/32 (0.2 logMAR) or better potential acuity in both eyes Exclusion Criteria: • Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye) Monocular status (e.g. amblyopia) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Diabetic retinopathy Macular pathology (e.g. ARMD, ERM) History of retinal detachment Subjects who have an unstable 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 any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivity mini-monovision<br>Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye. | Device: Vivity Extended Depth of Focus intraocular lens (IOL)<br>* Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Near Visual Acuity | binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative. | 3 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction Accuracy | Percentage of eyes with postoperative refractive accuracy within 0.5D of target | 3 months postop | 
| Spectacle Independence | Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - a little of the time or none of the time) | 3 months postop | 
| Patient Spectacle Independence | Patients reporting rarely or never needing glasses overall | 3 months postop | 
| Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely | This is the frequency of subjects responding, Never or Rarely to a question about the frequency of glare, halos and starbursts. | 3 months postop | 
| Manifest Refraction | Manifest refraction (residual spherical equivalent refraction) | 3 months postop | 
| Residual Cylinder | Residual refractive cylinder after surgery | 3 months | 
| Uncorrected Distance Visual Acuity | Bilateral uncorrected distance visual acuity | 3 months postop | 
| Uncorrected Intermediate Visual Acuity | Bilateral uncorrected visual acuity at 66 cm | 3 months postop | 
| Uncorrected Near Visual Acuity | Bilateral uncorrected near visual acuity at 40 cm | 3 months postop | 
| Corrected Distance Visual Acuity | Bliateral corrected distance visual acuity | 3 months postop | 
| Distance Corrected Intermediate Visual Acuity | Bliateral distance corrected visual acuity at 66 cm | 3 months postop |