Phase
Condition
Eye Disorders/infections
Eye Disease
Vision Loss
Treatment
Vivity IOL
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andunderwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOLat 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
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 ocularpathology, including moderate and severe dry eye, retina, optic nerve (includingglaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significantscarring), 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 maylimit 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 Description
Connect with a study center
LCSA Manhattan
New York, New York 10016
United StatesSite Not Available
LCSA White Plains
White Plains, New York 10605
United StatesSite Not Available
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