Cataract
Conditions
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.
Interventions
DEVICEVivity IOL
Vivity IOL
Sponsors
Sengi
Laser & Corneal Surgery Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular corrected distance visual acuity | 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular corrected visual acuity | 3 months after surgery | At distance, intermediate, and near |
| Binocular corrected visual acuity | 3 months after surgery | At intermediate and near |
| Binocular uncorrected visual acuity | 3 months after surgery | At distance, intermediate, and near |
| Monocular uncorrected visual acuity | 3 months after surgery | At distance, intermediate, and near |
| Satisfaction Questionnaire | 3 months after surgery | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. |
| Visual Disturbance Questionnaire | 3 months after surgery | Lower scores indicate less severe visual disturbances. |
| Refractive Outcomes | 3 months after surgery | Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism |
| Binocular Defocus curve | 3 months after surgery | — |
Countries
United States
Outcome results
None listed