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Low recruitment
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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL.
This study Prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Subjects will be assessed at least 3 months postoperatively. Clinical evaluations will include administration of a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity IOL | Device | Vivity IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular corrected distance visual acuity | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular uncorrected visual acuity | At distance, intermediate, and near | 3 months after surgery |
| Monocular corrected visual acuity | At distance, intermediate, and near |
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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.
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.
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.
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Eligible test subjects will be patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months ago.
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Y Hu, MD | Laser and Corneal Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LCSA Manhattan | New York | New York | 10016 | United States | ||
| LCSA White Plains |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months after surgery |
| Binocular corrected visual acuity | At intermediate and near | 3 months after surgery |
| Binocular uncorrected visual acuity | At distance, intermediate, and near | 3 months after surgery |
| Binocular Defocus curve | 3 months after surgery |
| Satisfaction Questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. | 3 months after surgery |
| Visual Disturbance Questionnaire | Lower scores indicate less severe visual disturbances. | 3 months after surgery |
| Refractive Outcomes | Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism | 3 months after surgery |
| White Plains |
| New York |
| 10605 |
| United States |