Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
- Conditions
- Cataract
- Interventions
- Device: Vivity IOL
- Registration Number
- NCT05961046
- Lead Sponsor
- Laser & Corneal Surgery Associates
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Vivity IOL Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL
- Primary Outcome Measures
Name Time Method Binocular corrected distance visual acuity 3 months after surgery
- Secondary Outcome Measures
Name Time Method Monocular corrected visual acuity 3 months after surgery At distance, intermediate, and near
Binocular 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.
Refractive Outcomes 3 months after surgery Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism
Visual Disturbance Questionnaire 3 months after surgery Lower scores indicate less severe visual disturbances.
Monocular uncorrected visual acuity 3 months after surgery At distance, intermediate, and near
Binocular corrected visual acuity 3 months after surgery At intermediate and near
Binocular Defocus curve 3 months after surgery
Trial Locations
- Locations (2)
LCSA Manhattan
🇺🇸New York, New York, United States
LCSA White Plains
🇺🇸White Plains, New York, United States
LCSA Manhattan🇺🇸New York, New York, United States