Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

Study Overview
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Brief Summary
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The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.

Official Title
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Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis

Conditions
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Cataract

Intervention / Treatment
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* Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to consent to study and cataract surgery Visually significant cataract Potential post-operative visual acuity of 20/25 or better Age 18 years or older Exclusion Criteria: Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss Irregular astigmatism Prior corneal refractive surgery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| trifocal intraocular lens<br> | Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses<br>* Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of spectacle independence (overall) | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 1 month post-cataract surgery | 
| Percentage spectacle independence (overall) | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 3 months post-cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectacle independence for distance, intermediate and near | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 1 month post-cataract surgery | 
| Spectacle independence for distance, intermediate and near | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 3 months post-cataract surgery | 
| Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE) | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 1 month post-cataract surgery | 
| Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE) | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 3 months post-cataract surgery | 
| Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target | This will be measured by visual acuity | 3 months post-cataract surgery | 
| Subject satisfaction | This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed. | 3 months post-cataract surgery | 
| Uncorrected binocular and monocular visual acuity at all distances | This will be measured by visual acuity | 3 months post-cataract surgery | 
| Distribution of residual refractive error | This will be measured by refractive error | 3 months post-cataract surgery | 
| Contrast sensitivity (binocular) | This will be measured by contrast sensitivity testing | 1 month post-cataract surgery | 
| Contrast sensitivity (binocular) | This will be measured by contrast sensitivity testing | 3 months post-cataract surgery | 
| Percentage of subjects with <=0.50 D of refractive cylinder | This will be measured by refractive error | 1 month post-cataract surgery | 
| Percentage of subjects with <=0.50 D of refractive cylinder | This will be measured by refractive error | 3 months post-cataract surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trifocal lens, trifocal intraocular lens, aberrometry