Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Last updated: April 9, 2025
Sponsor: Utah Eye Centers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

cataract surgery

Clinical Study ID

NCT06924944
UEC-101-001
  • All Genders

Study Summary

Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • o Bilateral age-related visually significant cataracts in otherwise healthy eyes,undergoing uncomplicated bilateral sequential Clareon Vivity IOLs

  • Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) withup to 1 enhancement treatment

  • Potential acuity measured post-operatively 20/25 or better in both eyes

  • Patients with regular astigmatism that can be managed with T3 toric lens orarcuate incision

Exclusion

Exclusion Criteria:

  • o Ocular or systemic comorbidities that may alter or reduce visual acuity andcontrast sensitivity such as severe dry eye/ocular surface disease, glaucoma,macular degeneration, retinopathy, neuro-ophthalmic diseases, etc.

  • Prior ocular surgeries other than uncomplicated corneal refractive surgery andexcluding RK

  • Patients with irregular astigmatism/topography (to rule out signs of potentialectasia), corneal dystrophies, and pupil abnormalities

  • Total HOA cutoff of ≤0.5, coma ≤0.3

  • RLE patients

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: cataract surgery
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Utah Eye Centers

    Ogden, Utah 84403
    United States

    Active - Recruiting

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