Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients (NCT05961046) | Clinical Trial Compass
TerminatedNot Applicable
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Stopped: Low recruitment
United States6 participantsStarted 2023-08-17
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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.
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