Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Vivity IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Adult (at least 40 years) 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 before enrollment. Monocular BCDVA 20/25 or better. Patients may be >2 weeks post-YAG capsulotomy for visually significant PCO. Post-operative sphere ≤0.50D, astigmatism ≤0.50D, and MRSE < 0.75D. 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. Patients with corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon. Patients undergoing cataract removal with MIGS procedure. Patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon. 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL | Device: Vivity IOL<br>* Vivity IOL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular corrected distance visual acuity |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |