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

NCT05961046 | Terminated FDA Device

• 1 other identifier: JH-23-01
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Binocular corrected distance visual acuity

  3 months after surgery

Secondary Outcomes (8)

• Monocular uncorrected visual acuity

  3 months after surgery

• Monocular corrected visual acuity

  3 months after surgery

• Binocular corrected visual acuity

  3 months after surgery

• Binocular uncorrected visual acuity

  3 months after surgery

• Binocular Defocus curve

  3 months after surgery

Study Arms (1)

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

Interventions

Vivity IOL DEVICE

Vivity IOL

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laser & Corneal Surgery Associates: lead
• Sengi: collaborator

Study Sites (2)

LCSA Manhattan

New York, New York, 10016, United States

Location

LCSA White Plains

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jimmy Y Hu, MD

  Laser and Corneal Surgery Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: August 17, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)