Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

Study Overview
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Brief Summary
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Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

Detailed Description
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A mini-monovision approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). This approach can have the benefit of increasing ability to see over a broad range of vision without glasses. The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients following cataract surgery. It has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. None of the procedures in this study are experimental. However, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the Clareon Vivity and Vivity Toric lenses.

Official Title
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Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

Conditions
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Aphakia, Postcataract

Intervention / Treatment
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* Device: Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using Clareon Vivity and Clareon Vivity Torics IOL powers between +10D to +30.0D, T3-T6 Potential acuity measured post-operatively 20/25 or better in both eyes Exclusion Criteria: History of ocular or refractive surgery Ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc. Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity Intraoperative or postoperative complications

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini-Monovision Arm<br>Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision. | Device: Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.<br>* Bilateral implantation of IOLs such that dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular distance is target-corrected visual acuity (VA) at near 40cm. | Increase in ability to see over a broad range of vision without glasses | 3 month post-surgery |