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

NCT ID: NCT05961046

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2024-06-13

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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL

Vivity IOL

Intervention Type: DEVICE

Vivity IOL

Interventions

Vivity IOL

Vivity IOL

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Laser & Corneal Surgery Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Y Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Laser and Corneal Surgery Associates

Locations

LCSA Manhattan

New York, New York, United States

LCSA White Plains

White Plains, New York, United States

Countries

United States

Other Identifiers

JH-23-01

Identifier Type: -

Identifier Source: org_study_id