Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Launched by UTAH EYE CENTERS · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of eye lens called the Clareon Vivity IOL on patients who have had previous vision correction surgeries, like LASIK or PRK, and are now dealing with cataracts. The goal is to see how well these lenses can help people see clearly at different distances—far, middle, and near—after their cataract surgery, while also minimizing any side effects during the day. Researchers want to understand whether the Clareon Vivity lenses can provide good vision outcomes for patients who might otherwise have unpredictable results due to their history of eye surgeries.

To participate in this trial, patients should be experiencing significant cataracts in both eyes and should have had uncomplicated vision correction surgery in the past. Eligible participants are those who can see well after surgery (at least 20/25 vision) and have specific types of astigmatism that can be treated with the study lenses. Participants can expect to undergo a straightforward cataract surgery where these new lenses will be implanted. It’s important to note that certain eye conditions or previous surgeries may disqualify someone from joining the study. Overall, this trial aims to help improve vision outcomes for people who have had prior eye surgeries and are facing new challenges with cataracts.

Gender

ALL

Eligibility criteria

• 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) 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 Criteria:
• • 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