Visual Outcomes After Vivity Toric IOL Implantation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.

Detailed Description
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To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.

Official Title
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Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens

Conditions
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Refractive Assessment

Intervention / Treatment
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* Other: Procedure: Vivity Toric IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6 Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator Exclusion Criteria: Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity Ocular trauma or zonular weakness/instability Diagnosis of glaucoma or high-risk glaucoma suspect Previous refractive surgery Unreliable preoperative biometry measurements Severe dry eye or ocular surface disease

Ages Eligible for Study
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Minimum Age: 45 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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vivity Toric IOL<br>Patients with cataract that had phacoemulsification and Vivity Toric IOL implantation. | Other: Procedure: Vivity Toric IOL<br>* The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular visual acuity at distance | Monocular uncorrected distance visual acuity | 4 months | 
| Binocular visual acuity at distance | Binocular uncorrected distance visual acuity | 4 months | 
| Monocular best corrected distance visual acuity | Monocular best corrected distance visual acuity | 4 months | 
| Binocular best corrected distance visual acuity | Binocular best corrected distance visual acuity | 4 months | 
| Monocular best distance-corrected intermediate visual acuity | Monocular best distance-corrected intermediate visual acuity | 4 months | 
| Binocular best distance-corrected intermediate visual acuity | Binocular best distance-corrected intermediate visual acuity | 4 months | 
| Monocular best distance-corrected near visual acuity | Monocular best distance-corrected near visual acuity | 4 months | 
| Binocular best distance-corrected near visual acuity | Binocular best distance-corrected near visual acuity | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual refractive cylinder | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vivity, Extended Vision Toric Intraocular Lens, Patient satisfaction and visual outcomes