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Clinical Trials/NCT05961046
NCT05961046TerminatedNot Applicable

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

Laser & Corneal Surgery Associates2 sites in 1 country6 target enrollmentStarted: August 17, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
6
Locations
2
Primary Endpoint
Binocular corrected distance visual acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •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.

Outcomes

Primary Outcomes

Binocular corrected distance visual acuity

Time Frame: 3 months after surgery

Secondary Outcomes

  • Binocular uncorrected visual acuity(3 months after surgery)
  • Satisfaction Questionnaire(3 months after surgery)
  • Refractive Outcomes(3 months after surgery)
  • Monocular corrected visual acuity(3 months after surgery)
  • Visual Disturbance Questionnaire(3 months after surgery)
  • Binocular Defocus curve(3 months after surgery)
  • Monocular uncorrected visual acuity(3 months after surgery)
  • Binocular corrected visual acuity(3 months after surgery)

Investigators

Sponsor
Laser & Corneal Surgery Associates
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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