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

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.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • LCSA Manhattan
    • White Plains, New York, United States, 10605
      • LCSA White Plains

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible test subjects will be 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 ago.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular corrected distance visual acuity	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular uncorrected visual acuity	At distance, intermediate, and near	3 months after surgery
Monocular corrected visual acuity	At distance, intermediate, and near	3 months after surgery
Binocular corrected visual acuity	At intermediate and near	3 months after surgery
Binocular uncorrected visual acuity	At distance, intermediate, and near	3 months after surgery
Binocular Defocus curve		3 months after surgery
Satisfaction Questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months after surgery
Visual Disturbance Questionnaire	Lower scores indicate less severe visual disturbances.	3 months after surgery
Refractive Outcomes	Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism	3 months after surgery

Collaborators and Investigators

• Sponsor: Laser & Corneal Surgery Associates
• Collaborators: Sengi
• Investigators: Principal Investigator: Jimmy Y Hu, MD, Laser and Corneal Surgery Associates

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JH-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes