Status:

RECRUITING

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Lead Sponsor:

Utah Eye Centers

Conditions:

Correction Vision Surgery

Cataract Surgery

Eligibility:

All Genders

Brief 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 n...

Eligibility Criteria

Inclusion

  • 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) with up 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 or arcuate incision

Exclusion

  • o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast 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 and excluding RK
  • Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities
  • Total HOA cutoff of ≤0.5, coma ≤0.3
  • RLE patients

Key Trial Info

Start Date :

January 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT06924944

Start Date

January 20 2025

End Date

April 1 2026

Last Update

April 13 2025

Active Locations (1)

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1

Utah Eye Centers

Ogden, Utah, United States, 84403