Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL |
Device: Vivity IOL
Vivity IOL
|
Outcome Measures
Primary Outcome Measures
- Binocular corrected distance visual acuity [3 months after surgery]
Secondary Outcome Measures
- Monocular uncorrected visual acuity [3 months after surgery]
At distance, intermediate, and near
- 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
- Binocular Defocus curve [3 months after surgery]
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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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.
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Monocular BCDVA 20/25 or better.
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Patients may be >2 weeks post-YAG capsulotomy for visually significant PCO.
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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.
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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.
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Patients undergoing cataract removal with MIGS procedure.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LCSA Manhattan | New York | New York | United States | 10016 |
| 2 | LCSA White Plains | White Plains | New York | United States | 10605 |
Sponsors and Collaborators
- Laser & Corneal Surgery Associates
- Sengi
Investigators
- Principal Investigator: Jimmy Y Hu, MD, Laser and Corneal Surgery Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JH-23-01