Actively Recruiting

All Genders
NCT06924944

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Led by Utah Eye Centers · Updated on 2025-04-13

35

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Bilateral age-related visually significant cataracts in otherwise healthy eyes
  • Undergoing uncomplicated bilateral sequential Clareon Vivity intraocular lens implantation
  • Prior history of uncomplicated myopic refractive surgery (LASIK or PRK) with up to one enhancement treatment
  • Potential postoperative visual acuity of 20/25 or better in both eyes
  • Presence of regular astigmatism manageable with T3 toric lens or arcuate incision
Not Eligible

You will not qualify if you...

  • Eye or systemic conditions that could reduce visual acuity or contrast sensitivity such as severe dry eye, ocular surface disease, glaucoma, macular degeneration, retinopathy, or neuro-ophthalmic diseases
  • Prior eye surgeries other than uncomplicated corneal refractive surgery, excluding radial keratotomy
  • Irregular astigmatism or topography suggesting possible ectasia, corneal dystrophies, or pupil abnormalities
  • Total higher order aberrations above 0.5 or coma above 0.3
  • Patients who have undergone refractive lens exchange

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Utah Eye Centers

Ogden, Utah, United States, 84403

Actively Recruiting

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Research Team

R

Rachel Buchanan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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