Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUtah Eye Centers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult subjects with bilateral age-related cataract patients with history of myopic refractive surgery (LASIK/PRK)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
cataract surgery
Procedure/Surgerycataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Binocular photopic uncorrected distance VA (at 3 months)
Time frame
at 3 monthsSecondary outcomes
1
• Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)
Time frame
at 3 monthsOther outcomes
1
Monocular uncorrected distance, intermediate, and near VA
Time frame
at 3 months2
Monocular and binocular best distance corrected distance, intermediate, and near VA
Time frame
at 3 months3
Binocular photopic low contrast distance corrected VA
Time frame
at 3 months4
Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye
Time frame
at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov