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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trifocal intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon Trifocal and Trifocal Toric Intraocular Lenses | Device | Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Brissette, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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 |