Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients

Last updated: June 13, 2024
Sponsor: Laser & Corneal Surgery Associates
Overall Status: Terminated

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

Vivity IOL

Clinical Study ID

NCT05961046
JH-23-01
  • Ages > 40
  • All Genders

Study 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.

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

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Vivity IOL
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
June 13, 2024

Study 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.

Connect with a study center

  • LCSA Manhattan

    New York, New York 10016
    United States

    Site Not Available

  • LCSA White Plains

    White Plains, New York 10605
    United States

    Site Not Available

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