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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
| The Eye Associates | OTHER |
| Eye Care Specialists | UNKNOWN |
| NewsomeEye |
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Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: Vivity ACRYSOF IQ IOL | Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens |
| |
| Control Group: ACRYSOF IQ IOL | Control Group: Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity ACRYSOF IQ IOL Group | Device | Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Distance Visual Acuity (BCDVAA) | Best correct distance visual acuity | After 1 year post-op |
| Best Corrected Intermediate Visual Acuity (BCIVA) | Best correct intermediate visual acuity | After 1 year post-op |
| Defocus Curve | After 1 year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) | Uncorrected Distance Visual Acuity | After 1 year post-op |
| UCNVA | Uncorrected Near Visual Acuity |
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Inclusion Criteria:
Must have participated in the FDA study at one of the included sites
Exclusion Criteria:
None
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45-60 subjects will be enrolled (30-45 subjects that received the Vivity IOL and 15-20 subjects that received the control lens in the FDA clinical trial) across up to five investigational sites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| UNKNOWN |
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| ACRYSOF IQ IOL Control Group | Device | Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens |
|
| After 1 year post-op |
| Dyphotopsia rate | Demonstrated by responses on questionnaire | After 1 year post-op |
| Post-operative IOLSAT | Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome | After 1 year post-op |
| (Post-operative QUVID) | Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome | After 1 year post-op |