Visual Outcomes of Vivity in Patients With High Axial Length

Study Overview
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Brief Summary
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The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.

Detailed Description
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This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.

Official Title
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Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length

Conditions
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Cataract

Intervention / Treatment
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* Device: Vivity


Participation Criteria
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Eligibility Criteria
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Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Inclusion Criteria: Undergoing uncomplicated bilateral cataract surgery with IOL implantation. Gender: Males and Females. Age: 50 years 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. Motivated for greater degree of spectacle independence vs monofocal IOL. Axial length ≥24.5mm in both eyes. Planned cataract removal by femtosecond laser. 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. Ocular comorbidity that might hamper postoperative visual acuity. Previous refractive surgery. Irregular corneal astigmatism. Evidence of keratoconus as per Pentacam. Expected post-op VA worse than 20/25 (Snellen). Refractive lens exchange. Difficulties comprehending written or spoken English language. Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate). Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion. Axial length <24.5mm. Evidence of macular pathology as per optical coherence tomography examination. 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: 50 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 |
| --- | --- |
| Bilateral implantation of the Vivity IOL<br>Vivity intraocular lens (IOL) | Device: Vivity<br>* Vivity intraocular lens (IOL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular uncorrected distance visual acuity | Binocular uncorrected distance visual acuity | 3 months | 
| Binocular uncorrected intermediate visual acuity | Binocular uncorrected intermediate visual acuity | 3 months | 
| Binocular uncorrected near visual acuity | Binocular uncorrected near visual acuity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction error | Percentage of eyes with absolute prediction error of 0.5D or less | 3 months | 
| Binocular best-corrected distance visual acuity | Binocular best-corrected distance visual acuity | 3 months | 
| Binocular best-corrected intermediate visual acuity | Binocular best-corrected intermediate visual acuity | 3 months | 
| Binocular best-corrected near visual acuity | Binocular best-corrected near visual acuity | 3 months | 
| Monocular best-corrected distance visual acuity | Monocular best-corrected distance visual acuity | 3 months | 
| Monocular best-corrected intermediate visual acuity | Monocular best-corrected intermediate visual acuity | 3 months | 
| Monocular best-corrected near visual acuity | Monocular best-corrected near visual acuity | 3 months | 
| Manifest refraction | Residual spherical equivalent refraction, residual sphere, and residual astigmatism | 3 months | 
| Questionnaire | Questionnaire for visual disturbance scores (QUVID) | 3 months | 
| Questionnaire | Patient satisfaction questionnaire scores (IOLSAT) | 3 months | 
| Binocular distance-corrected low contrast distance visual acuity | Binocular distance-corrected low contrast distance visual acuity | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EDOF IOL Vivity