Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cataract surgery.
- Who it may be relevant to
- Registry conditions: Correction Vision Surgery, Cataract Surgery. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Procedure cataract surgery
cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL
Primary outcome measures
- Binocular photopic uncorrected distance VA (at 3 months) [Time frame: at 3 months]
Secondary outcome measures (1)
- • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm) [Time frame: at 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Utah Eye Centers — Ogden
Identifiers
NCT: NCT06924944 · UEC-101-001