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This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.
Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.
This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.
All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon Vivity or Vivity Toric IOL | Device | Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?" | Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?" | 8/1/2020 - 7/1/2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?" | Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?" | 8/1/2020 - 7/1/2021 |
| Percentage of postoperative patients who report that they do not require reading glasses for various activities |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?" | Percentage of patients reporting "very satisfied" when asked, "Overall, how satisfied are you with your vision after your latest surgery?" | 8/1/2020 - 7/1/2021 |
| Percentage of patients who report "very satisfied" or "satisfied" to the same question. |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing cataract surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States | ||
| Quentin Allen |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked "For what types of activities do you need glasses to see (other than sunglasses)?" |
| 8/1/2020 - 7/1/2021 |
Percentage of patients who report "very satisfied" or "satisfied" to the same question. |
| 8/1/2020 - 7/1/2021 |
| Palm City |
| Florida |
| 34990 |
| United States |
| Quantum Vision Center | Edwardsville | Illinois | 62025 | United States |