Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

Study Overview
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Brief Summary
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The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.

Detailed Description
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This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.

Official Title
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Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

Conditions
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Cataract

Intervention / Treatment
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* Device: Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer


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. Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL. Gender: Males and Females. Age: 45 or older. Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena. 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). 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 (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity. Irregular corneal astigmatism and keratoconus. Post refractive eyes (i.e. LASIK or PRK or SMILE). Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate). Angle Kappa/chord mu ≥0.6. Higher order corneal aberrations: > 0.6 total RMS, >0.3 coma, >0.3 trefoil (to exclude irregular corneas). 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

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer|Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular refractive target accuracy | Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D. | 10 Weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction error | Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D | 10 Weeks postoperative | 
| Mean absolute prediction error |  | 10 Weeks postoperative | 
| Median absolute prediction error |  | 10 Weeks postoperative | 
| Uncorrected monocular visual acuity | at distance (6m), intermediate (60cm), and near (40cm) | 10 Weeks postoperative | 
| Distance corrected monocular visual acuity | at distance (6m), intermediate (60cm), and near (40cm) | 10 Weeks postoperative | 
| Manifest refraction |  | 10 Weeks postoperative | 
| Back-calculated Residual Astigmatism (BRA) | using preoperative cylinder power (for toric IOLs) | 10 Weeks postoperative |